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| ID | Type | Description | Link |
|---|---|---|---|
| ENG_2020_04 | Other Identifier | Ethicon Endo-Surgery |
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The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures | Experimental | Any thoracic, urologic, or ENT procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. Participants will be considered enrolled when the ENSEAL X1 device has been attempted to be used for a vessel transection during thoracic, urologic, or ENT procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENSEAL X1 Curved Jaw Tissue Sealer | Device | ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). Here, the number of vessels that achieved <=Grade 3 hemostasis was reported. | On the day of transection (Day 0) |
| Number of Participants With at Least One Device-related Adverse Events (AEs) | Device-related AEs were those having a relationship of possibly, probably, or causally. 1. Possible-The relationship with use of device was weak but cannot be ruled out completely. Alternative causes were also possible. Cases where relatedness cannot be assessed, or no information had been obtained were also classified as possible. 2. Probable -The relationship with use of device seemed relevant and/or event cannot reasonably be explained by another cause, but additional information may be obtained; 3. Causal relationship-The event was associated with device or with procedures beyond reasonable doubt with event occurred such as, a known side effect; temporal relationship; involves a body-site or organ that device was applied or had an effect on; followed a known response pattern; impact on event when discontinued and reintroduced; Others; Harms due to error in use. | Baseline up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1. | On the day of transection (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethicon Endo-Surgery Clinical Trial | Ethicon Endo-Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Hospital | Omaha | Nebraska | 68114 | United States | ||
| National Cancer Center Hospital East |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Siegel JM, Cummings JF, Clymer JW. Reproducible, repeatable and clinically-relevant hemostasis scoring. J Adv Med Pharm Sci 2014;1:30-39. |
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Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | ENSEAL X1 | All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2021 | Oct 20, 2023 |
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| Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatics bundles division by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue bundles division by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue grasping by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue cutting by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue dissection by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale | A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). Here, the number of vessels that achieved Grade 1 to 4 hemostasis was reported. | On the day of transection (Day 0) |
| Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips | Percentage of grade 4 vessel transections requiring hemostasis measures such as sutures and hemoclips were reported. | On the day of transection (Day 0) |
| Chiba |
| Japan |
| Kitasato University | Kanagawa | Japan |
| Kanagawa Cancer Center | Yokohama | Japan |
| Zuyderland Medical Center | Sittard | Netherlands |
| Western General Hospital | Edinburgh | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ENSEAL X1 | All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). Here, the number of vessels that achieved <=Grade 3 hemostasis was reported. | ENSEAL X1 analysis set included all participants whose vessels were transected and analyzed during the procedures. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure. | Posted | Count of Units | vessels transected | On the day of transection (Day 0) | vessels transected | vessels transected |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With at Least One Device-related Adverse Events (AEs) | Device-related AEs were those having a relationship of possibly, probably, or causally. 1. Possible-The relationship with use of device was weak but cannot be ruled out completely. Alternative causes were also possible. Cases where relatedness cannot be assessed, or no information had been obtained were also classified as possible. 2. Probable -The relationship with use of device seemed relevant and/or event cannot reasonably be explained by another cause, but additional information may be obtained; 3. Causal relationship-The event was associated with device or with procedures beyond reasonable doubt with event occurred such as, a known side effect; temporal relationship; involves a body-site or organ that device was applied or had an effect on; followed a known response pattern; impact on event when discontinued and reintroduced; Others; Harms due to error in use. | ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. | Posted | Count of Participants | Participants | Baseline up to 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1. | ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatics bundles division by ENSEAL X1. | ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue bundles division by ENSEAL X1. | ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue grasping by ENSEAL X1. | ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue cutting by ENSEAL X1. | ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue dissection by ENSEAL X1. | ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale | A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). Here, the number of vessels that achieved Grade 1 to 4 hemostasis was reported. | ENSEAL X1 analysis set included all participants whose vessels were transected and analyzed during the procedures. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure. | Posted | Count of Units | vessels transected | On the day of transection (Day 0) | vessels transected | vessels transected |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips | Percentage of grade 4 vessel transections requiring hemostasis measures such as sutures and hemoclips were reported. | ENSEAL X1 analysis set included all participants whose vessels were transected and analyzed during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure and the number of vessels transected analyzed included only vessels that were transected and analyzed for this outcome measure. | Posted | Number | percentage of vessel transections | On the day of transection (Day 0) | vessels transected | vessels transected |
|
|
Baseline up to 6 weeks
ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENSEAL X1 | All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures. | 0 | 94 | 4 | 94 | 22 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Escherichia urinary tract infection | Infections and infestations | MedDRA version 23 | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 23 | Non-systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA version 23 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA version 23 | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA version 23 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA version 23 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Catheter site extravasation | General disorders | MedDRA version 23 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA version 23 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA version 23 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA version 23 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA version 23 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 23 | Non-systematic Assessment |
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| Suprapubic pain | General disorders | MedDRA version 23 | Non-systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA version 23 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 23 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 23 | Non-systematic Assessment |
| |
| Confusion postoperative | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Drain site complication | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Post procedural constipation | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
| |
| Post procedural hypotension | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Wound secretion | Injury, poisoning and procedural complications | MedDRA version 23 | Non-systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Heart rate increased | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Oxygen consumption increased | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Urine output | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Urine output decreased | Investigations | MedDRA version 23 | Non-systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 23 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 23 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 23 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA version 23 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 23 | Non-systematic Assessment |
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| Petit mal epilepsy | Nervous system disorders | MedDRA version 23 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA version 23 | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA version 23 | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA version 23 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA version 23 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA version 23 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 23 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA version 23 | Non-systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA version 23 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Non-systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 23 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 23 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 23 | Non-systematic Assessment |
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| Venous haemorrhage | Vascular disorders | MedDRA version 23 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MEDICAL DIRECTOR LCM Compliance | Ethicon Endo-Surgery, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2022 | Oct 20, 2023 | SAP_001.pdf |
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| vessels transected |
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| vessels transected |
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