Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2

NCT ID: NCT00580502

Last Updated: 2015-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2012-09-30

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

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LAGB for low BMI patients

the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities

Group Type: EXPERIMENTAL

LAP-BAND® Adjustable Gastric Band (LAGB®)

Intervention Type: DEVICE

Bariatric surgery for patient whose BMI is between 30 and 40 kg/m\^2

Interventions

LAP-BAND® Adjustable Gastric Band (LAGB®)

Bariatric surgery for patient whose BMI is between 30 and 40 kg/m\^2

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Heekoung A Youn

Research coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Ren-Fielding, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYUSOM

Related Links

http://nyuweightloss.org

NYU Program for Surgical Weight Loss

Other Identifiers

10686

Identifier Type: OTHER

Identifier Source: secondary_id

G030190

Identifier Type: OTHER

Identifier Source: secondary_id

H # 10686

Identifier Type: -

Identifier Source: org_study_id