Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)
Stopped early
Conditions studied: Weight Loss
In brief
This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes * Weight Loss * Co-morbid disease resolution
Key facts
- Study ID
- NCT01497028
- Run by
- Jacksonville Surgical Associates
- Starts
- 2011-11-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2015-04-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must meet the following criteria to be eligible for study entry:
- Age between 18 - 80 years, and
- Severely or Morbidly obese:
- BMI > 35, or
- BMI > 30 + co-morbid obesity related disease condition
- Without any contraindications to bariatric surgery, and
- Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
- Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain
You may not qualify if…
- Subjects meeting the following criteria will be excluded from study entry:
- Any patient not meeting the inclusion criteria
- Patients with any major medical problems contraindicating surgery
- Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
- Patients who elect to undergo a surgery other than a PLAGB or SLAGB
- Pregnant or planning pregnancy within 12 months
- Alcohol or drug addiction
- Established infection anywhere in the body at the time of surgery
- Previous history of other bariatric surgery (except LAGB)
- Family or patient history of autoimmune disease
Where it is running
- Ventura Advanced Surgical Associates — Ventura, California, United States
- Jacksonville Surgical Associates — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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