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Completed

NCT Number: NCT04544865

Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

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.

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Key information

Conditions

Gastric Procedures Lung Resection Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Staple Line Reinforcement

Device

ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.

Primary outcomes

  1. Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures

    Time frame: From Day 0 (day of surgery) through 70 days post-surgery

    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).

  2. Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days

    Time frame: From Day 0 (day of surgery) through 70 days post-surgery

    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).

Secondary outcomes

  1. Number of Study Devices Replaced During Surgery

    Time frame: Day 0 (Intra-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.

  2. Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback

    Time frame: Day 0 (Intra-surgery)

    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.

  3. Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback

    Time frame: Day 0 (Intra-surgery)

    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.

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 10, 2020
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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