Status:
TERMINATED
Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)
Lead Sponsor:
Jacksonville Surgical Associates
Conditions:
Weight Loss
Eligibility:
All Genders
18-80 years
Brief Summary
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 ou...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01497028
Start Date
November 1 2011
End Date
October 1 2014
Last Update
April 3 2015
Active Locations (2)
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1
Ventura Advanced Surgical Associates
Ventura, California, United States, 93003
2
Jacksonville Surgical Associates
Jacksonville, Florida, United States, 32216