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| Name | Class |
|---|---|
| Syneos Health | OTHER |
Not provided
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This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with TachoSil for the management of minimal, mild, or moderate bleeding during elective open liver surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GATT-Patch (currently named ETHIZIA) | Experimental | Hemostatic patch |
|
| TachoSil | Active Comparator | Hemostatic patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GATT-Patch (currently named ETHIZIA) | Device | GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location. GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point | Surface Bleeding Severity Scale 0 | During surgical procedure, assessed up to 10 minutes after device application |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to Hemostasis (Seconds) | Surface Bleeding Severity Scale 0 | During surgical procedure, assessed up to 10 minutes or up to the time that hemostasis is achieved, whichever occurred last |
| Kaplan-Meier Estimated Distribution of Time to Hemostasis |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | Time in minutes | During surgical procedure |
| Estimated Blood Loss | mL | During surgical procedure |
Inclusion Criteria:
A subject must meet all of the following intra-operative inclusion criteria to be enrolled into the clinical investigation:
Exclusion Criteria:
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| James Guarrera | Rutgers New Jersey Medical School, Newark, NJ, USA | Principal Investigator |
| Hans de Wilt | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28699748 | Background | Boerman MA, Roozen E, Sanchez-Fernandez MJ, Keereweer AR, Felix Lanao RP, Bender JCME, Hoogenboom R, Leeuwenburgh SC, Jansen JA, Van Goor H, Van Hest JCM. Next Generation Hemostatic Materials Based on NHS-Ester Functionalized Poly(2-oxazoline)s. Biomacromolecules. 2017 Aug 14;18(8):2529-2538. doi: 10.1021/acs.biomac.7b00683. Epub 2017 Jul 25. | |
| 34536065 |
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| ID | Title | Description |
|---|---|---|
| FG000 | GATT-Patch (Currently Named ETHIZIA) | Hemostatic patch GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location. GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver. |
| FG001 | TachoSil | Hemostatic patch TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GATT-Patch (Currently Named ETHIZIA) | Hemostatic patch GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location. GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point | Surface Bleeding Severity Scale 0 | Per protocol population | Posted | Count of Participants | Participants | During surgical procedure, assessed up to 10 minutes after device application |
|
3 months
ISO14155 and FDA definitions for AEs and SAEs
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GATT-Patch (Currently Named ETHIZIA) | Hemostatic patch GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location. GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra abdominal fluid collection | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
There was a difference in initial evaluation time between ETHIZIA and TachoSil, which followed the products' specific application procedures. TachoSil was chosen as comparator because it is considered current standard-of-care. To optimize its performance, the 3-minute application time for TachoSil adhered to its IFU, rather than being aligned to ETHIZIA's 30-second application time. The 3-minute mark for primary efficacy corresponds with various prior studies on THA in liver surgery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Head MD PhD | GATT Technologies | +31645306042 | shead2@its.jnj.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2023 | Jan 20, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2023 | Jan 20, 2026 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C518955 | TachoSil |
Not provided
Not provided
Not provided
Randomization 2:1
Not provided
Not provided
Patients will be blinded to randomized treatment and treatment used.
|
| TachoSil | Drug | TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. |
|
Surface Bleeding Severity Scale 0 |
| During surgical procedure, up to the time that hemostasis is achieved |
| Rate of Subjects With Treatment Failure | SBSS 1-5 at the 10 minute timepoint | During surgical procedure |
| Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure | Surface Bleeding Severity Scale 1-5 after initially Surface Bleeding Severity Scale 0 | During surgical procedure up to patient closure |
| Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds | Surface Bleeding Severity Scale 0-5 | During surgical procedure up to 10 minutes after device application |
| Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma | Platelets, Erythrocytes, Plasma | During surgical procedure |
| Number and Type of Blood Transfusions | Platelets, Erythrocytes, Plasma | During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days |
| Mean Duration of ICU Stay | Time in hours | From surgery to discharge from the ICU, estimated up to 30 days |
| Mean Total Hospitalization Time | Time in days | During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days |
| Aspect of Postoperative Drainage | Serous, sanguineous, serosanguineous, other Sanguineous Serosanguinous Serous, Sanguineous, Serosanguineous, Purulent, Other | During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days |
| Rate of Subjects Requiring Reoperation | Occurrence yes/no | During postoperative 3-months follow-up |
| Rate of Subjects With Liver Resection Surface Complications on Ultrasound | Patch encapsulation, patch rolling up on the surface, pseudoaneurysm, fluid collection | At 6 weeks follow-up visit |
| Amount of Hemostatic Material Needed Versus Bleeding Surface | cm2 patch per cm2 bleeding | During surgical procedure |
| System Usability Score (SUS) User Satisfaction Questionnaire | Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome for uneven questions and (strongly) disagreeing meaning a better outcome for even questions | At completion of the surgical procedure, at day 0 |
| GATT-Patch Device-specific User Satisfaction Questionnaire | Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome | At completion of the surgical procedure, at day 0 |
| Local Recurrence of Liver Cancer at the Resection | Occurrence yes/no | 5 years |
| Cancer-free Survival | Occurrence yes/no | 5 years |
| Overall Survival | Occurrence yes/no | 5 years |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Rutgers University | Newark | New Jersey | 07103 | United States |
| Weill-Cornell | New York | New York | 10065 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Intermountain Healthcare | Murray | Utah | 84111 | United States |
| Heidelberg University Hospital | Heidelberg | Germany |
| University Medical Center Groningen | Groningen | Netherlands |
| Radboud University Medical Center | Nijmegen | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| Roozen EA, Warle MC, Lomme RMLM, Felix Lanao RP, van Goor H. New polyoxazoline loaded patches for hemostasis in experimental liver resection. J Biomed Mater Res B Appl Biomater. 2022 Mar;110(3):597-605. doi: 10.1002/jbm.b.34938. Epub 2021 Sep 18. |
| 42177141 | Derived | Guarrera JV, Kaur N, Verhoef C, Zendejas I, Botha J, Fouraschen SMG, Paterno F, Pianka F, Porte RJ, Samstein B, Sher L, Wellen JR, Bender JCME, Fossan I, Head SJ, de Wilt JHW; ETHIZIA Open Liver Study Collaborator Group. Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled multicenter trial. HPB (Oxford). 2026 May 7:S1365-182X(26)00612-X. doi: 10.1016/j.hpb.2026.04.466. Online ahead of print. |
| BG001 | TachoSil | Hemostatic patch TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | TachoSil | Hemostatic patch TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. |
|
|
| Secondary | Mean Time to Hemostasis (Seconds) | Surface Bleeding Severity Scale 0 | Per protocol population | Posted | Median | Inter-Quartile Range | seconds | During surgical procedure, assessed up to 10 minutes or up to the time that hemostasis is achieved, whichever occurred last |
|
|
|
| Secondary | Kaplan-Meier Estimated Distribution of Time to Hemostasis | Surface Bleeding Severity Scale 0 | Posted | Count of Participants | Participants | During surgical procedure, up to the time that hemostasis is achieved |
|
|
|
| Secondary | Rate of Subjects With Treatment Failure | SBSS 1-5 at the 10 minute timepoint | Intention-to-treat population | Posted | Count of Participants | Participants | During surgical procedure |
|
|
|
| Secondary | Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure | Surface Bleeding Severity Scale 1-5 after initially Surface Bleeding Severity Scale 0 | Intention-to-treat population | Posted | Count of Participants | Participants | During surgical procedure up to patient closure |
|
|
|
| Secondary | Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds | Surface Bleeding Severity Scale 0-5 | Intention-to-treat population | Posted | Count of Participants | Participants | During surgical procedure up to 10 minutes after device application |
|
|
|
| Other Pre-specified | Procedure Duration | Time in minutes | Intention-to-treat population | Posted | Median | Full Range | Minutes | During surgical procedure |
|
|
|
| Other Pre-specified | Estimated Blood Loss | mL | Intention-to-treat population | Posted | Median | Inter-Quartile Range | mL | During surgical procedure |
|
|
|
| Other Pre-specified | Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma | Platelets, Erythrocytes, Plasma | Safety population | Posted | Count of Participants | Participants | During surgical procedure |
|
|
|
| Other Pre-specified | Number and Type of Blood Transfusions | Platelets, Erythrocytes, Plasma | Intention-to-treat population | Posted | Count of Participants | Participants | During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days |
|
|
|
| Other Pre-specified | Mean Duration of ICU Stay | Time in hours | Intention-to-treat population | Posted | Median | Inter-Quartile Range | Hours | From surgery to discharge from the ICU, estimated up to 30 days |
|
|
|
| Other Pre-specified | Mean Total Hospitalization Time | Time in days | Intention-to-treat population | Posted | Median | Inter-Quartile Range | Days | During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days |
|
|
|
| Other Pre-specified | Aspect of Postoperative Drainage | Serous, sanguineous, serosanguineous, other Sanguineous Serosanguinous Serous, Sanguineous, Serosanguineous, Purulent, Other | Not Posted | During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days | Participants |
| Other Pre-specified | Rate of Subjects Requiring Reoperation | Occurrence yes/no | Intention-to-treat population | Posted | Count of Participants | Participants | During postoperative 3-months follow-up |
|
|
|
| Other Pre-specified | Rate of Subjects With Liver Resection Surface Complications on Ultrasound | Patch encapsulation, patch rolling up on the surface, pseudoaneurysm, fluid collection | Intention-to-treat population with imaging performed | Posted | Count of Participants | Participants | At 6 weeks follow-up visit |
|
|
|
| Other Pre-specified | Amount of Hemostatic Material Needed Versus Bleeding Surface | cm2 patch per cm2 bleeding | Intention to treat | Posted | Median | Inter-Quartile Range | Size of patch applied per cm2 bleeding | During surgical procedure |
|
|
|
| Other Pre-specified | System Usability Score (SUS) User Satisfaction Questionnaire | Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome for uneven questions and (strongly) disagreeing meaning a better outcome for even questions | Intention to treat with the questionnaire completed | Posted | Number | participants | At completion of the surgical procedure, at day 0 |
|
|
|
| Other Pre-specified | GATT-Patch Device-specific User Satisfaction Questionnaire | Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome | Intention to treat with questionnaire completed | Posted | Number | participants | At completion of the surgical procedure, at day 0 |
|
|
|
| Other Pre-specified | Local Recurrence of Liver Cancer at the Resection | Occurrence yes/no | Not Posted | 5 years | Participants |
| Other Pre-specified | Cancer-free Survival | Occurrence yes/no | Not Posted | 5 years | Participants |
| Other Pre-specified | Overall Survival | Occurrence yes/no | Not Posted | 5 years | Participants |
| 5 |
| 87 |
| 37 |
| 87 |
| 66 |
| 87 |
| EG001 | TachoSil | Hemostatic patch TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. | 1 | 43 | 10 | 43 | 31 | 43 |
| Ascites | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Postoperative abscess | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Pneumonitis aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (27.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Lymphatic fistula | Vascular disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA (27.0) | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Investigations | Investigations | MedDRA (27.0) | Non-systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D004066 | Digestive System Diseases |
| 90 seconds |
|
| 120 seconds |
|
| 150 seconds |
|
| 180 seconds |
|
| 210 seconds |
|
| 240 seconds |
|
| 270 seconds |
|
| 300 seconds |
|
| 360 seconds |
|
| 420 seconds |
|
| 480 seconds |
|
| 540 seconds |
|
| 600 seconds |
|
| At closure |
|
| Hemostasis achieved at 90 seconds |
|
| Hemostasis achieved at 120 seconds |
|
| Hemostasis achieved at 150 seconds |
|
| Hemostasis achieved at 180 seconds |
|
| Hemostasis achieved at 210 seconds |
|
| Hemostasis achieved at 240 seconds |
|
| Hemostasis achieved at 270 seconds |
|
| Hemostasis achieved at 300 seconds |
|
| Hemostasis achieved at 360 seconds |
|
| Hemostasis achieved at 420 seconds |
|
| Hemostasis achieved at 480 seconds |
|
| Hemostasis achieved at 540 seconds |
|
| Hemostasis achieved at 600 seconds |
|
| Not achieved within 10 minutes |
|
| Plasma |
|
| None |
|
| Plasma |
|
| Other |
|
| None |
|
| Pseudoaneurysm |
|
| Fluid Collection |
|
| N/A |
|
|
| Neutral/Disagreed with "I think I would need support of a technical person to use GATT-Patch" |
|
| Neutral/Agree with "I found the various functions in GATT-Patch well integrated" |
|
| Neutral/Disagreed with "I thought there was too much inconsistency in GATT-Patch" |
|
| Neutral/Agreed with "I would imagine that most people would learn to use GATT-Patch very quickly" |
|
| Neutral/Disagreed with "I found GATT-Patch very cumbersome to use" |
|
| Neutral/Agreed with "I felt very confident using GATT-Patch" |
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| Neutral/Disagreed with "I needed to learn a lot of things before I could get going with GATT-Patch" |
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| Neutral/Agree "It is clear that GATT-Patch should be used within 1 hour after opening the blister" |
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| Neutral/Agree "It is clear on which organs GATT-Patch is allowed to be used" |
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| Neutral/Agree "It is clear on which organs GATT-Patch is not allowed to be used" |
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| Neutral/Agree "It is clear for what severity of bleeding GATT-Patch can be used" |
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| Neutral/Agree "It is clear what contraindications of a patient prohibit use of GATT-Patch" |
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| Neutral/Agree "The information in the instructions for use is sufficient" |
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| Neutral/Agree "The packaging is easy to open without damaging GATT-Patch" |
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| Neutral/Agree "The size of GATT-Patch is adequate for its intended purpose" |
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| Neutral/Agree "A dry GATT-Patch does not stick to dry gloves and instruments" |
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| Neutral/Agree "GATT-Patch is easy to cut with dry scissors" |
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| Neutral/Agree "GATT-Patch can be handled with dry tweezers without damaging/fragmenting" |
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| Neutral/Agree "It is clear that GATT-Patch should be applied with a wet gauze for a period of 30s" |
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| Neutral/Agree "It is clear that GATT-Patch should be applied overlapping the bleeding by 1 cm" |
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| Neutral/Agree "GATT-Patch is pliable on irregular tissue when applied with a wet gauze" |
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| Neutral/Agree "The wet gauze can be carefully and safely removed without damaging GATT-Patch" |
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| Neutral/Agree "GATT-Patch stays in place after application" |
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| Neutral/Agree "It is easy to ensure that GATT-Patch is fully hydrated after application" |
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| Neutral/Agree "It is clear how to apply a GATT-Patch (partly) on top of another GATT-Patch" |
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| Neutral/Agree "The maximum number of GATT-Patches used in a patient is clear" |
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| Neutral/Agree "The blue color helps to visualize GATT-Patch after application" |
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| Neutral/Agree "Safe to remove excess non-adherent GATT-Patch without damaging adherent GATT-Patch" |
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| Neutral/Agree "GATT-Patch can be used intuitively" |
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| Neutral/Agree "I feel confident that GATT-Patch stops a bleeding" |
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| Neutral/Agree "I feel confident that GATT-Patch can be used safely" |
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| Neutral/Agree "GATT-Patch is easy to be used/handled" |
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| Neutral/Agree "It is clear what to do with the Implant Card (only applicable for patients in EU)" |
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