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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Heekoung A Youn, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00580502
First received: December 21, 2007
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
Diabetes Mellitus
 Device: LAP-BAND® Adjustable Gastric Band (LAGB®)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity
U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • To determine if the laparoscopic adjustable gastric band is a safe and effective procedure for patients with BMI between 30-40 kg/m2 with co-morbidities. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine long-term effects on patient health and co-morbidities, including: 1. Nutritional status 2. Improvement of pre-operative co-morbidities 3. Improvement of Quality of life 4. Weight loss maintenance 5. Need for re-operation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: March 2004
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lap-Band
Low BMI patients who will go through Lap-band surgery.
 Device: LAP-BAND® Adjustable Gastric Band (LAGB®)
Bariatric surgery: LAGB
Other Name: Lap-Band; Adjustable gastric banding system

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580502

Sponsors and Collaborators
New York University School of Medicine
Allergan
Investigators
Principal Investigator: Christine Youn, M.D. NYUSOM
  More Information

Additional Information:
NYU Program for Surgical Weight Loss  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Heekoung A Youn, Research coordinator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00580502     History of Changes
Other Study ID Numbers: H # 10686, H#10686, G030190
Study First Received: December 21, 2007
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Obesity, 50 lbs overweight
DM

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013