Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01497028

Enrollment

Unknown

Registered

2011-12-22

Start date

2011-11-30

Completion date

2014-10-31

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Keywords

Co-morbid disease resolution

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 outcomes * Weight Loss * Co-morbid disease resolution

Interventions

PROCEDUREPLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.

PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Design outcomes

Primary

Measure	Time frame
Weight Loss	3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026