Obesity
Conditions
Keywords
gastrojejunostomy, stoma
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.
Interventions
PROCEDURETissue plication
Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System
DEVICEEndoscopic Suturing System
Tissue plication of dilated GJ stoma
DEVICETissue Plication
Tissue plication for GJ stoma reduction
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knotting Elements Placed | intra-operative | completion of plication (1-3 knotting elements placed per procedure) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tissue Plication | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Tissue Plication |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 35.5 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Outcome results
Primary
Knotting Elements Placed
completion of plication (1-3 knotting elements placed per procedure)
Time frame: intra-operative
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tissue Plication | Knotting Elements Placed | 11 elements |