NCT00283972

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 31, 2006

Status Verified

January 1, 2006

First QC Date

January 24, 2006

Last Update Submit

January 30, 2006

Conditions

Epworth Sleepiness ScaleGlycemic ControlLiver FunctionInflammationIron and Bone TurnoverSF-36IW-QOL Lite HRQoL

Keywords

Health Outcome Study

Interventions

LAP-BAND SystemDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Deykin, MD

    Massachusetts Veterans Epidemiology Research adn Information Center

    STUDY CHAIR

  • Louis Fiore, MD

    Massachusetts Veterans Epidemiology Research and Information Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 31, 2006

Study Start

June 1, 2005

Study Completion

December 1, 2006

Last Updated

January 31, 2006

Record last verified: 2006-01