Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283972
Status:
UNKNOWN
Last Update Posted:
2006-01-31
First Post:
2006-01-24
Brief Title:
LAP-BAND Observational Cohort
Sponsor:
Inamed
Organization:
Inamed
Study Overview
Official Title:
Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
To prospectively observe the association of the LAP-BAND procedure on quality of life anthropometric metabolic and biochemical parameters in morbidly obese patients when performed by experienced US surgeons The study will also include a complete economic analysis of the LAP-BAND procedure and follow-up costs Hypothesis Measurements defining quality of life and the severity of obesity and obesity related comorbidities improve significantly over baseline with the LAP-BAND System treatment at 6 and 12 months post surgery when performed by an experienced surgeon
Detailed Description:
Study Type Observational cohort Single arm non-comparative non-randomized multi-site surgical case series
Objective To prospectively observe the association of the LAP-BAND System device on measurements of quality of life anthropometric metabolic and biochemical parameters in morbidly obese patients when performed by experienced US surgeons Cost effectiveness analysis will also be done
Numbers This study will enroll 240 patients total from six US bariatric surgical practices
Duration Individual subject participation will be approximately 15 months Data will be collected at a baseline less than three months prior to surgery or before starting a Very Low Calorie Diet VLCD then at 6 and 12 months post surgery The total duration including enrollment of the observational period for the cohort is expected to be 21 months Subjects have the option to consent for future contact by investigators for a period of 10 years following their surgery
Objective To prospectively observe the association of the LAP-BAND System device on measurements of quality of life anthropometric metabolic and biochemical parameters in morbidly obese patients when performed by experienced US surgeons Cost effectiveness analysis will also be done
Numbers This study will enroll 240 patients total from six US bariatric surgical practices
Duration Individual subject participation will be approximately 15 months Data will be collected at a baseline less than three months prior to surgery or before starting a Very Low Calorie Diet VLCD then at 6 and 12 months post surgery The total duration including enrollment of the observational period for the cohort is expected to be 21 months Subjects have the option to consent for future contact by investigators for a period of 10 years following their surgery
Study Oversight
Has Oversight DMC:
None
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?:
None