Clinical trial NCT00495222: Endoscopic Suturing System for Tissue Apposition
Official title: Evaluation of an Endoscopic Suturing System for Tissue Apposition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: gastrojejunostomy
stoma
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2007-07-03
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Knotting Elements Placed
timeFrame: intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alfonso Torquati, MD
role: PRINCIPAL_INVESTIGATOR
References: