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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 renal artery and renal 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 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 |
|---|---|---|
| Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions | Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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 2.6 hours, ranging from 42 minutes to 6.4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding | Proportion of participants with hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the Renal Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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In total, 302 subjects were screened, 270 subjects were randomized, and those 32 subjects who were not randomized did not satisfy inclusion or exclusion criteria.
Recruitment was from July 2016 to July 2017 across 11 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 | Mean |
| 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 | Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions | Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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). | All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection. | Posted | Number | 95% Confidence Interval | proportion of transected vessels | Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours | Vessels Transected | Vessels Transected |
|
4 Weeks Post Procedure
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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 |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers | Ethicon | 513-337-1172 | mschwier@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 17, 2015 | Aug 21, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2017 | Aug 21, 2018 | SAP_001.pdf |
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| Device |
|
| Post-Op through 4 Week Follow-up |
| 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 |
|
| Standard of Care |
Facility's Current Instrumentation |
| OG001 | Powered Vascular Stapler | Use of the ECHELON FLEX™ Powered Vascular Stapler |
|
|
| Secondary | Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding | Proportion of participants with hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the Renal Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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). | All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection. | Posted | Number | 95% Confidence Interval | proportion of participants | Post-Op through 4 Week Follow-up |
|
|
|
| 139 |
| 21 |
| 139 |
| 26 |
| 139 |
| EG001 | Powered Vascular Stapler | Use of the ECHELON FLEX™ Powered Vascular Stapler | 0 | 131 | 14 | 131 | 33 | 131 |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Retroperitoneal hematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Post procedural hemmorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post-operative ileus | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Genital pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Wound drainage | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
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