Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

NCT04544865 | Completed Results FDA Device

• 1 other identifier: ESC_2018_03
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

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.

Conditions

Gastric Procedures; Lung Resection Procedures

Keywords

Buttress, gastrectomy, gastric bypass, lung volume reduction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Study Devices Replaced During Surgery

  Day 0 (Intra-surgery)

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

  Day 0 (Intra-surgery)

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

  Day 0 (Intra-surgery)

Study Arms (1)

Gastric and thoracic staple line reinforcement

EXPERIMENTAL

ECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure.

Device: Staple Line Reinforcement

Interventions

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.

Gastric and thoracic staple line reinforcement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (8)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

University of Missouri

Columbia, Missouri, 65201, United States

Location

Long Island Jewish Medical Center

New York, New York, 11040, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Results Point of Contact

• Title: SENIOR DIRECTOR OF CLINICAL AFFAIRS
• Organization: Ethicon Endo-Surgery

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• 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

  Corewell Health West

  PRINCIPAL INVESTIGATOR

• Kenneth Kesler, MD

  Indiana University Health

  PRINCIPAL INVESTIGATOR

• Emily Cassidy, MD

  Our Lady of the Lake Hospital

  PRINCIPAL INVESTIGATOR

• Keith Gersin, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Linda Martin, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 10, 2020
• Study Start: September 29, 2020
• Primary Completion: October 17, 2022
• Study Completion: February 8, 2023
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (8)