Endoscopic Suturing System for Tissue Apposition
September 8, 2009 updated by: Ethicon Endo-Surgery
Evaluation of an Endoscopic Suturing System for Tissue Apposition
The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Post-procedure weight will be followed to assess whether weight loss is resumed.
The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to facilitate endoscopic gastrointestinal procedures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
Subjects must fulfill the following criteria to be entered in this study:
- Review and sign informed consent;
- Between 21 and 65 years of age (inclusive) at time of trial enrollment;
- Documented Roux-en-Y Gastric Bypass (RYGB) surgery date
- Documented baseline weight at the time of RYGB procedure;
- > 12 months post RYGB);
- Body mass Index (BMI) > 30 and at least 20 pounds in excess of post-RYGB weight nadir;
- Patients initially achieved at least 50% excess weight loss (EWL) post RYGB;
- Visible anastomotic junction (between gastric pouch and the Roux-limb);
- Stoma size at screening > 15mm; and
- Negative serum pregnancy test for women of childbearing potential.
Exclusion Criteria
Subjects will be excluded from the trial for any of the following:
- Documented history of esophageal pathology (e.g., esophageal varices, Barrett's Esophagus);
- American Anesthesia Association (ASA) Class IV or V and/or any contraindications to monitored anesthesia;
- Documented history of GJ anastomosis stricture (within 6 months);
- Documented history of previous RYGB revision;
- Presence or documented presence of gastric/duodenal ulcers;
- Presence of sepsis;
- Medical or physical endoscopic contraindications, including esophageal varices or bleeding, laryngeal perforation, trauma to pharynx, aspiration pneumonia, acute peritonitis, and other conditions where general endoscopic techniques and/or placement of overtube are contraindicated;
- Chronic Non-Steroidal Anti-Inflammatory Drug (NSAID) use (subjects taking a single aspirin tablet per day for cardioprotection are considered acceptable);
- Uncontrolled diabetes;
- Physical or psychological condition which would impair trial participation per investigator discretion;
- Binge-eating or similar eating disorders;
- Unable or unwilling to attend follow-up visits and examinations;
- Concurrent surgical procedure (intra-operative exclusion during ESS procedure);
- Participation in any other investigational device or drug trial within 30 days prior to enrollment; or
- Any condition, which precludes compliance with the trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tissue plication
The Endoscopic Suturing System (ESS) is used for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass
|
Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System
Tissue plication of dilated GJ stoma
Tissue plication for GJ stoma reduction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knotting Elements Placed
Time Frame: intra-operative
|
completion of plication (1-3 knotting elements placed per procedure)
|
intra-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alfonso Torquati, MD, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
June 29, 2007
First Submitted That Met QC Criteria
July 2, 2007
First Posted (Estimate)
July 3, 2007
Study Record Updates
Last Update Posted (Estimate)
September 10, 2009
Last Update Submitted That Met QC Criteria
September 8, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CI-06-0005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.