Status:
COMPLETED
Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
Lead Sponsor:
Ponce, Jaime, M.D.
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 in...
Detailed Description
The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with other restrictive procedures (i.e., gas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01207609
Start Date
November 1 2010
End Date
January 1 2016
Last Update
February 2 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton Medical Center
Dalton, Georgia, United States, 30722
2
Chattanooga Bariatrics
Chattanooga, Tennessee, United States, 37421