Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

NCT00721227 | Completed Results

• 1 other identifier: CI-07-0005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Successful Gastric Plication Using Reduction Gastroplasty

  The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.

  Immediately post-operative

Secondary Outcomes (2)

• Durability of Gastric Plications Following Reduction Gastroplasty

  12 month

• Weight Loss Following Reduction Gastroplasty

  12 months

Study Arms (2)

Anterior Curve

ACTIVE COMPARATOR

Reduction Gastroplasty by Gastric Plication on Anterior Curve

Procedure: Reduction Gastroplasty

Greater Curve

ACTIVE COMPARATOR

Reduction Gastroplasty by Gastric Plication on Greater Curve

Procedure: Reduction Gastroplasty

Interventions

Reduction Gastroplasty PROCEDURE

* Subjects will undergo reduction gastroplasty by gastric plication * Subjects are followed for 12 months to evaluate outcomes and potential complications.

Anterior Curve; Greater Curve

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects are considered appropriate candidates for the study if they fulfill the following criteria:
• Subject is willing to give consent and comply with evaluation and treatment schedule;
• to 60 years of age (inclusive);
• BMI \> 35 kg/m2 and \< 50 kg/m2 (BMI 35-40 kg/m2 allowable with one or more significant medical conditions related to obesity, including co-morbid conditions of hyperlipidemia, mild obstructive sleep apnea (per Investigators discretion), hypertension, or osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss);
• Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria);
• Absence of significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, per site standard of care (SOC); and
• Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial.

You may not qualify if:

• Subjects will be excluded from the study for any of the following:
• Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
• Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
• Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;
• Scheduled concurrent surgical procedure;
• Participation in any other investigational device or drug study (non survey based trial) 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;
• Treatment with insulin (more than 50 units a day);
• Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
• Cirrhosis;

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

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: Amy Mahanes, Senior Clinical Research Associate
• Organization: Ethicon Endo Surgery, Inc.

amahanes@its.jnj.com

513-337-8366

Study Officials

• Philip R Schauer, M.D

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 24, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 8, 2010
• Results First Posted: August 18, 2010

Record last verified: 2010-09

Locations

US (1)