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Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544865
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Study Description
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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
Gastric Procedures Lung Resection Procedures Device: Staple Line Reinforcement Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 243 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-Arm, Multi-Center Study of the ECHELON ENDOPATH(TM) Staple Line Reinforcement Device in Gastric and Lung Resection Procedures
Actual Study Start Date : September 29, 2020
Estimated Primary Completion Date : June 3, 2022
Estimated Study Completion Date : August 26, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of device-related adverse events (AEs) in gastric procedures [ Time Frame: 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


  2. Incidence of device-related adverse events (AEs) in lung resection procedures [ Time Frame: 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 :
  1. Devices replaced during surgery due to slipping, bunching, or improper loading [ Time Frame: Intra-operative ]
    Number of study devices replaced during surgery due to slipping, bunching, or not properly loaded onto stapler cartridge


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544865


Contacts
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Contact: Study Contact (513) 337-8564 RA-ZEPPELIN-ESC2018@ITS.JNJ.com

Locations
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United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maryanne Bowyer-Cherry, RN       mbowyer@iupui.edu   
United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Julie Doyle       Julie.Doyle@fmolhs.org   
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Lillian Hayes       LHAYES4@hfhs.org   
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Pamela Merrill, RN       pamela.merrill@spectrumhealth.org   
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65201
Contact: Sarah Brown       brownsarah@health.missouri.edu   
Principal Investigator: Andrew Wheeler, MD         
United States, New York
Long Island Jewish Medical Center Recruiting
New York, New York, United States, 11040
Contact: Efstathia Mihelis       EMihelis@northwell.edu   
United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Katheryn Peterson       Katheryn.Peterson@atriumhealth.org   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Luke Allen       lja9d@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
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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 Atrium Health
Principal Investigator: Linda Martin, MD University of Virginia
More Information
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Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT04544865    
Other Study ID Numbers: ESC_2018_03
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ethicon Endo-Surgery:
Buttress, gastrectomy, gastric bypass, lung volume reduction