Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
Study Details
Study Description
Brief Summary
This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gastric and thoracic staple line reinforcement ECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure. |
Device: Staple Line Reinforcement
ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.
|
Outcome Measures
Primary Outcome Measures
- Incidence of device-related adverse events (AEs) in gastric procedures [70 days (+/- 14 days) post-operative]
Specific device-related AEs that will be captured and counted toward the primary endpoint for gastric procedures are: Bleeding: Occurrence of post-operative blood transfusion deemed related to bleeding at the staple line or return to operating room before 70-day post-procedure follow-up visit due to bleeding deemed related to the staple line; Leak: Occurrence of intra-operative or post-operative gastrointestinal leak related to the staple line as documented intra-operatively, by clinical exam, or radiographically; Stricture: Occurrence of stricture documented radiographically or by endoscopy along the staple line
- Incidence of device-related adverse events (AEs) in lung resection procedures [70 days (+/- 14 days) post-operative]
Specific device-related AEs that will be captured and counted toward the primary endpoint for lung resection procedures are: Prolonged air leak greater than postoperative day 7 deemed related to the staple line; Empyema: Purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema
Secondary Outcome Measures
- Devices replaced during surgery due to slipping, bunching, or improper loading [Intra-operative]
Number of study devices replaced during surgery due to slipping, bunching, or not properly loaded onto stapler cartridge
Eligibility Criteria
Criteria
Inclusion Criteria:
- Primary procedure (gastric or lung resection) where the ECHELON SLR is planned to be used for reinforcement of staple lines per the IFU in either a or b:
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Gastric procedures limited to laparoscopic gastric resection, robotic laparoscopic gastric resection, partial gastrectomy, gastric wedge resection, subtotal gastrectomy, laparoscopic Roux-en-Y gastric bypass, and robotic laparoscopic gastric bypass; or
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Lung resection procedures that include lobectomy, segmentectomy or wedge resection, and lung volume reduction surgery, and may be video assisted thoracic surgery (VATS) or open procedures;
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Willingness to give consent and comply with all study-related evaluations and visit schedule; and
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At least 18 years of age.
Exclusion Criteria:
- Preoperative:
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Physical or psychological condition which would impair study participation;
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Body mass index (BMI) ≥ 46.0 kg/m2;
-
The procedure is a revision/reoperation for the same indication or same anatomical location;
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A procedure where extended wound or organ support is required;
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Any medical condition that the investigator deems could impact inflammatory or immune response;
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Concurrent treatment with medications that the investigator deems could have influence on wound healing;
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History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or
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Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
- Intraoperative:
- Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Health | Indianapolis | Indiana | United States | 46202 |
| 2 | Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana | United States | 70808 |
| 3 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 4 | Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 5 | University of Missouri | Columbia | Missouri | United States | 65201 |
| 6 | Long Island Jewish Medical Center | New York | New York | United States | 11040 |
| 7 | Atrium Health | Charlotte | North Carolina | United States | 28203 |
| 8 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
Sponsors and Collaborators
- Ethicon Endo-Surgery
Investigators
- Principal Investigator: Andrew Popoff, MD, Henry Ford Health System
- Principal Investigator: David Zeltsman, MD, Long Island Jewish Medical Center
- Principal Investigator: Andrew Wheeler, MD, University of Missouri-Columbia
- Principal Investigator: Jon Schram, MD, Spectrum Health Hospitals
- Principal Investigator: Kenneth Kesler, MD, Indiana University Health
- Principal Investigator: Emily Cassidy, MD, Our Lady of the Lake Regional Medical Center
- Principal Investigator: Keith Gersin, MD, Wake Forest University Health Sciences
- Principal Investigator: Linda Martin, MD, University of Virginia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESC_2018_03