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This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein transection) and powered vascular stapler.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgeon's 'standard of care' stapler | Active Comparator | Surgeon's current standard of care stapler |
|
| Ethicon Powered Vascular Stapler | Experimental | Ethicon Powered Vascular Stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgeon's 'standard of care' stapler | Device |
| ||
| Ethicon Powered Vascular Stapler |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intra-Operative Hemostatic Intervention | Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open). | Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS:
No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection). |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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229 subjects signed an informed consent, 201 were randomized into one of the two groups. The 28 not randomized did not meet the inclusion criteria.
Recruitment was from Feb 2016 to Feb 2017 across 7 hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Facility's Current Instrumentation |
| FG001 | Powered Vascular Stapler | Use of the ECHELON FLEX™ Powered Vascular Stapler |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Facility's Current Instrumentation |
| BG001 | Powered Vascular Stapler | Use of the ECHELON FLEX™ Powered Vascular Stapler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant Age in Years |
| 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 | Incidence of Intra-Operative Hemostatic Intervention | Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open). | A total of 229 subjects were screened and 201 subjects were randomized into the study - 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS group. These subjects are included in the stapler group for the primary endpoint analysis, consistent with the intention-to-treat principle. | Posted | Number | 95% Confidence Interval | Proportion transections w/ intervention | Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours | Vessels Transection | Vessels Transection |
4 Weeks Post Procedure
For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
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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 | Standard of Care | Facility's Current Instrumentation | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Waggoner, PhD | Ethicon Endo Surgery | +1 513.337.8310 | jwaggon1@its.jnj.com |
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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 | Nov 11, 2015 | Mar 29, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2017 | Mar 29, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Device |
|
| Post-Op through 4 Week Followup |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Standard of Care | Facility's Current Instrumentation |
| OG001 | Powered Vascular Stapler | Use of the ECHELON FLEX™ Powered Vascular Stapler |
|
|
| Secondary | Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS:
No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection). | A total of 229 subjects were screened and 201 subjects were randomized into the study - 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS stapler. These subjects are included in the PVS group for safety analysis. | Posted | Number | 95% Confidence Interval | Proportion participants w/ intervention | Post-Op through 4 Week Followup | Participant | Participant |
|
|
|
| 96 |
| 22 |
| 96 |
| 35 |
| 96 |
| EG001 | Powered Vascular Stapler | Use of the ECHELON FLEX™ Powered Vascular Stapler | 0 | 105 | 18 | 105 | 33 | 105 |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | Systematic Assessment |
|
| Cystitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | Systematic Assessment |
|
| Infarction | Vascular disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |