Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication

NCT01077193 | Terminated Results

• 1 other identifier: CI-09-0006
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 3

Brief Summary

Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.

Conditions

Morbid Obesity

Keywords

Bariatric; Obesity

Outcome Measures

Primary Outcomes (1)

• Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward

  Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL

  3 years

Study Arms (1)

Gastric Plication Surgery

OTHER

Procedure: Gastric Plication

Interventions

Gastric Plication PROCEDURE

A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.

Gastric Plication Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is willing to give consent and comply with evaluation and treatment schedule (for female patients, this includes agreement to use a reliable (per investigator) form of birth control for the duration of the trial);
• to 65 years of age (inclusive);
• Subject meets ASMBS and NIH criteria: (consensus.nih.gov)
• BMI ³ 40 kg/m2 and £ 50 kg/m2; or, BMI 35-40 kg/m2 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss, including:
• Hyperlipidemia
• Mild obstructive sleep apnea (per Investigator discretion)
• Hypertension
• Osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated;
• ASA Class I - III;
• Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;
• HbA1C \< 11%; and
• For subjects who have Type 2 diabetes, medication regimen is no more complex (2 oral medications) than oral metformin plus one oral sulfonylurea plus once daily insulin injection.

You may not qualify if:

• Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
• Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
• Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
• Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
• Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring \> 2 medications, or history of suicide attempts;
• Participation in any other investigational device or drug study (non-survey based trial; long-term enrollment in such studies as requiring periodic laboratory tests, etc., would be allowed) within 12 weeks of enrollment;
• Any condition which precludes compliance with the study, including:
• Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
• Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
• Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
• Uncontrolled hypertension;
• Portal hypertension;
• Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
• Cirrhosis;
• Congenital or acquired intestinal telangiectasia;

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (3)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

OB Klinika, a.s.

Prague, Czechia

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael L. Schwiers
• Organization: Ethicon-Endo Surgery, Inc.

mschwier@its.jnj.com

513-337-1172

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 7, 2014
• Results First Posted: September 13, 2013

Record last verified: 2014-01

Locations

CZ (1); US (2)