Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

Weight Loss Clinical Trial

Official title:

Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01497028
• Other study ID #: PLAGB
• Status: Terminated
• Phase: N/A
• First received: November 22, 2011
• Last updated: April 2, 2015
• Start date: November 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2011
• Source: Jacksonville Surgical Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Weight Loss

Intervention

Procedure:
• PLAGB 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.

Locations

Country	Name	City	State
United States	Jacksonville Surgical Associates	Jacksonville	Florida
United States	Ventura Advanced Surgical Associates	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Jacksonville Surgical Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss		3 years	No