LAP-BAND Observational Cohort | NCT00283972

Studies
LAP-BAND Observational Cohort

NCT00283972

Sponsor

Inamed

Status

Unknown status

Last Update Posted

Jan 31, 2006Estimated

Enrollment

240

Phase

Not provided

Conditions

Epworth Sleepiness Scale
Glycemic Control
Liver Function
Inflammation
Iron and Bone Turnover
SF-36
IW-QOL Lite HRQoL

Interventions

LAP-BAND System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Jan 24, 2006

First Submission Date that Met QC Criteria

Jan 30, 2006

First Posted Date

Jan 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2006

Last Update Posted Date

Jan 31, 2006Estimated

Name	Class
Massachusetts Veterans Epidemiology Research and Information Center	FED

Description Module

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 U.S. surgeons. Cost effectiveness analysis will also be done.

Numbers: This study will enroll 240 patients total from six U.S. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Name	Type	Description	Arm Group Labels	Other Names
LAP-BAND System	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Morbid Obesity: BMI >40 kg/m2 or
BMI > or equal to 35 kg/m2 with significant obesity related comorbidity
Age 18 years old or older
Dietary attempts at weight control have been ineffective
Consented for surgery with LAP-BAND System by pre qualified bariatric surgeon
Willingness and ability to follow protocol requirements
Residing within a reasonable distance from the surgeon's office and being able to travel to the surgeon's office to complete all routine follow-up visits

Exclusion Criteria:

Previous bariatric surgery
Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Deykin, MD	Massachusetts Veterans Epidemiology Research adn Information Center	Study Chair
Louis Fiore, MD	Massachusetts Veterans Epidemiology Research and Information Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided