Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

Completed · Not applicable

Conditions studied: Morbid Obesity

In brief

The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity. The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.

Key facts

Study ID

NCT01207609

Run by

Ponce, Jaime, M.D.

People needed

35

Starts

2010-11-01

Expected to finish

2016-01-01

Last updated by the study team

2016-02-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 - 60 years
• BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2
• Willingness to comply with dietary restrictions required by the protocol
• History of obesity for at least 5 years
• History of at least 6 months of documented failures with traditional non-surgical weight loss methods
• Willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire
• If female with childbearing potential, using an appropriate form of contraception

You may not qualify if…

• Age less than 18, age greater than 60
• Pregnancy
• History of major depressive disorder or psychosis
• Previous bariatric surgery or previous gastric surgery
• Presence of achalasia
• Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study

Where it is running

• Hamilton Medical Center — Dalton, Georgia, United States
• Chattanooga Bariatrics — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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