Weight Loss Clinical Trial
Official title:
Prospective Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding
Verified date | September 2013 |
Source | Tenet Healthcare Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age older than 18 years - Morbidly Obese - BMI >40 or - BMI >35 plus co-morbid obesity related disease conditions - Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease - Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi Exclusion Criteria: - Any patient not meeting the inclusion criteria - Patients with any major medical problems contraindicating surgery - Patients with a medically treatable cause of obesity - Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding - Alcohol or drug addiction - Established infection anywhere in the body at the time of surgery - Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis - Family or patient history of autoimmune disease |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Des Peres Hospital | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Tenet Healthcare Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss | Weight loss 4 weeks post surgical:20% additional than without plication, 3months post surgical: 30% additional than without plication, 6 months post surgical:30-40% additional than without plication, 1 year post surgical = 30-40% additional than without plication & at 1 year patient will require 50% fewer adjustments than without plication. | at least 1 year | No |
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