Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

NCT ID: NCT04544865

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2023-02-08

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.

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.

Conditions

Gastric Procedures; Lung Resection Procedures

Keywords

Buttress, gastrectomy, gastric bypass, lung volume reduction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gastric and thoracic staple line reinforcement

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

Group Type: EXPERIMENTAL

Staple Line Reinforcement

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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:

1. 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

2. 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:

1. Physical or psychological condition which would impair study participation;

2. Body mass index (BMI) ≥ 46.0 kg/m2;

3. The procedure is a revision/reoperation for the same indication or same anatomical location;

4. A procedure where extended wound or organ support is required;

5. Any medical condition that the investigator deems could impact inflammatory or immune response;

6. Concurrent treatment with medications that the investigator deems could have influence on wound healing;

7. History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or

8. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

• Intraoperative:

9. Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Popoff, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

David Zeltsman, MD

Role: PRINCIPAL_INVESTIGATOR

Long Island Jewish Medical Center

Andrew Wheeler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Jon Schram, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Kenneth Kesler, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Health

Emily Cassidy, MD

Role: PRINCIPAL_INVESTIGATOR

Our Lady of the Lake Hospital

Keith Gersin, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Linda Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Indiana University Health

Indianapolis, Indiana, United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Henry Ford Health System

Detroit, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Long Island Jewish Medical Center

New York, New York, United States

Atrium Health

Charlotte, North Carolina, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ESC_2018_03

Identifier Type: -

Identifier Source: org_study_id