Epworth Sleepiness ScaleNCT00283972
LAP-BAND Observational Cohort
An observational study of Epworth Sleepiness Scale and Glycemic Control, run by Inamed.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epworth Sleepiness Scale, Glycemic Control, Liver Function
- What is being tested?
- LAP-BAND System
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous bariatric surgery
- Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons
About this study
Official title: Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
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.
Read the 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.
- Conditions
- Epworth Sleepiness Scale, Glycemic Control, Liver Function, Inflammation, Iron and Bone Turnover, SF-36
- Being tested
- LAP-BAND System
- Keywords
- Health Outcome Study
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAP-BAND SystemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJun 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epworth Sleepiness ScaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Inamed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts Veterans Epidemiology Research and Information Center
- Investigators
- Daniel Deykin, MD, Study chair, Massachusetts Veterans Epidemiology Research adn Information CenterLouis Fiore, MD, Principal investigator, Massachusetts Veterans Epidemiology Research and Information Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283972
- Sponsor's protocol ID
- 12242004P
- Status last verified
- Jan 2006
- First submitted
- 24 Jan 2006
- Last updated
- 31 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
- ClinicalTrials.gov ID
- NCT00283972
- Acronym / sponsor ID
- 12242004P
- Conditions
- Epworth Sleepiness Scale, Glycemic Control, Liver Function, Inflammation, Iron and Bone Turnover, SF-36
- Keywords
- Health Outcome Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants
- Lead sponsor
- InamedIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts Veterans Epidemiology Research and Information Center
- Study start
- Jun 2005
- Study completion
- Dec 2006
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Previous bariatric surgery
- Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAP-BAND System | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Deykin, MD study chair
Massachusetts Veterans Epidemiology Research adn Information Center
Louis Fiore, MD principal investigator
Massachusetts Veterans Epidemiology Research and Information Center
Questions about this trial
What is this clinical trial studying?
An observational study of Epworth Sleepiness Scale and Glycemic Control, run by Inamed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2006.