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

NYU Langone Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obesity

Treatments: Device: LAP-BAND® Adjustable Gastric Band (LAGB®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00580502

10686 (Registry Identifier)

H # 10686

G030190 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

LAGB for low BMI patients

Experimental group

Description:

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

Treatment:

Device: LAP-BAND® Adjustable Gastric Band (LAGB®)