NCT00495222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 11, 2009

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

June 29, 2007

Results QC Date

April 21, 2009

Last Update Submit

September 8, 2009

Conditions

Obesity

Keywords

gastrojejunostomystoma

Outcome Measures

Primary Outcomes (1)

  • Knotting Elements Placed

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

    intra-operative

Study Arms (1)

Tissue plication

EXPERIMENTAL

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 plicationDevice: Endoscopic Suturing SystemDevice: Tissue Plication

Interventions

Tissue PlicationPROCEDURE

Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System

Tissue plication
Endoscopic Suturing SystemDEVICE

Tissue plication of dilated GJ stoma

Tissue plication

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Participation in any other investigational device or drug trial within 30 days prior to enrollment; or
  • Any condition, which precludes compliance with the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Susan Knippenberg
Organization
Ethicon Endo-Surgery
sknippen@its.jnj.com
513 337-3452

Study Officials

  • Alfonso Torquati, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 3, 2007

Study Start

February 1, 2007

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

September 10, 2009

Results First Posted

August 11, 2009

Record last verified: 2009-09

Locations

US(1)