Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Single-Arm, Multi-Center Study of the ECHELON ENDOPATH(TM) Staple Line Reinforcement Device in Gastric and Lung Resection Procedures

Conditions
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Gastric Procedures, Lung Resection Procedures

Intervention / Treatment
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* Device: Staple Line Reinforcement


Participation Criteria
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Eligibility Criteria
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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: 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 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; Willingness to give consent and comply with all study-related evaluations and visit schedule; and At least 18 years of age. Exclusion Criteria: - Preoperative: Physical or psychological condition which would impair study participation; Body mass index (BMI) ≥ 46.0 kg/m2; The procedure is a revision/reoperation for the same indication or same anatomical location; A procedure where extended wound or organ support is required; Any medical condition that the investigator deems could impact inflammatory or immune response; Concurrent treatment with medications that the investigator deems could have influence on wound healing; History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric and thoracic staple line reinforcement<br>ECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure. | Device: Staple Line Reinforcement<br>* ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures | Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line). | From Day 0 (day of surgery) through 70 days post-surgery | 
| Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days | Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema). | From Day 0 (day of surgery) through 70 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Study Devices Replaced During Surgery | Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported. | Day 0 (Intra-surgery) | 
| Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response was ranged from 1 to 5 where 1=strongly disagree, 2=slightly disagree,3=neutral, 4=slightly agree, 5= strongly agree, where the higher response signified good experience on the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and 5th procedure were reported. | Day 0 (Intra-surgery) | 
| Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and fifth procedure were reported. | Day 0 (Intra-surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buttress, gastrectomy, gastric bypass, lung volume reduction