Clinical trial NCT00580502: Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
Official title: A Prospective Study to Evaluate the Safety and Efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) Operations for Patients With BMI Between 30-40 kg/m2 With Co-morbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: Obesity, 50 lbs overweight
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2007-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.

Detailed description: TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities

CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA

STUDY OBJECTIVES

* To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
* To determine long-term effects on patients' co-morbidities

STUDY VARIABLES: Morbidity \& mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation

DESIGN: Prospective single center study

Eligibility criteria: Inclusion Criteria:

* Be at least 18 and equal to or less than 60 years of age.
* BMI of at least 30 and maximum BMI of 40 with co-morbidities
* Willingness to comply with dietary restrictions required by the protocol
* History of obesity for at least 5 years
* History of at least 6 months of documented failures with traditional non-surgical weight loss methods
* Willingness to follow protocol requirements
* If female with childbearing potential, using an appropriate form of contraception

Exclusion Criteria:

* Age less than 18, age greater than 60
* Pregnancy
* History of major depressive disorder or psychosis
* Previous bariatric surgery or previous gastric surgery
* Presence of achalasia
* Presence of portal hypertension, cirrhosis, and/or varices
* Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
* Patients with autoimmune connective tissue disorders
* Patients with acute abdominal infections
* Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study

Primary outcomes:
measure: To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
timeFrame: 5 years
Secondary outcomes:
measure: Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
timeFrame: 5 years
measure: Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
timeFrame: 5 years
measure: Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: NYUSOM
name: Christine Ren-Fielding, M.D.
role: PRINCIPAL_INVESTIGATOR
References: