Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-22 @ 3:33 AM
Study NCT ID:
NCT00580502
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
Sponsor:
NYU Langone Health
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LBMI
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: