Endoscopic Suturing System for Tissue Apposition

• Sponsor: Ethicon Endo-Surgery (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00495222
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: Tissue plication; Device: Endoscopic Suturing System; Device: Tissue Plication	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of an Endoscopic Suturing System for Tissue Apposition
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

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	Procedure: Tissue plication; Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System; Device: Endoscopic Suturing System; Tissue plication of dilated GJ stoma; Device: Tissue Plication; Tissue plication for GJ stoma reduction

Outcome Measures

Primary Outcome Measures

1. Knotting Elements Placed [intra-operative]

   completion of plication (1-3 knotting elements placed per procedure)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Ethicon Endo-Surgery

Investigators

• Principal Investigator: Alfonso Torquati, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00495222
• Other Study ID Numbers: CI-06-0005
• First Posted: Jul 3, 2007
• Last Update Posted: Sep 10, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: gastrojejunostomy; stoma

Study Results

Participant Flow

Arm/Group Title	Tissue Plication
Arm/Group Description
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Tissue Plication
Arm/Group Description
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.5 (5.5)
Sex: Female, Male (Count of Participants)
Female	7 77.8%
Male	2 22.2%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Knotting Elements Placed
Description	completion of plication (1-3 knotting elements placed per procedure)
Time Frame	intra-operative

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Tissue Plication
Arm/Group Description
Measure Participants	9
Number [elements]	11

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.