Safety and Efficacy of 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: March 16, 2015
Last verified: March 2015

December 21, 2007
March 16, 2015
March 2004
September 2012   (final data collection date for primary outcome measure)
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.
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 ]
Complete list of historical versions of study NCT00580502 on ClinicalTrials.gov Archive Site
  • Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in level of LDL from baseline at 5 years
  • Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in level of Triglycerides from baseline at 5 years
  • Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in level of HbA1c from baseline at 5 years
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 ]
Not Provided
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Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
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
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.

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

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Device: LAP-BAND® Adjustable Gastric Band (LAGB®)
Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2
Experimental: LAGB for low BMI patients
the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
Intervention: Device: LAP-BAND® Adjustable Gastric Band (LAGB®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00580502
H # 10686, 10686, G030190
Yes
Not Provided
Not Provided
Heekoung A Youn, New York University School of Medicine
New York University School of Medicine
Allergan
Principal Investigator: Christine Ren-Fielding, M.D. NYUSOM
New York University School of Medicine
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP