ObesityPhase 2/3LBMINCT00580502

Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2

A Phase 2/3 study testing LAP-BAND® Adjustable Gastric Band (LAGB®) in people with Obesity, run by NYU Langone Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Obesity
What is being tested?: LAP-BAND® Adjustable Gastric Band (LAGB®)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: Mar 2004to Sep 2012
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Be at least 18 and equal to or less than 60 years of age.
BMI of at least 30 and maximum BMI of 40 with co-morbidities
Willingness to comply with dietary restrictions required by the protocol
History of obesity for at least 5 years
History of at least 6 months of documented failures with traditional non-surgical weight loss methods
Willingness to follow protocol requirements
If female with childbearing potential, using an appropriate form of contraception

Who cannot join

Age less than 18, age greater than 60
Pregnancy
History of major depressive disorder or psychosis
Previous bariatric surgery or previous gastric surgery
Presence of achalasia
Presence of portal hypertension, cirrhosis, and/or varices

Show all 10Show fewer

Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
Patients with autoimmune connective tissue disorders
Patients with acute abdominal infections
Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study

About this study

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

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.

Read the 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

Conditions: Obesity
Being tested: LAP-BAND® Adjustable Gastric Band (LAGB®)
Keywords: Obesity, 50 lbs overweight
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LAP-BAND® Adjustable Gastric Band (LAGB®)Device
Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2

Study groups in NCT00580502
Study group	Role	What they receive
LAGB for low BMI patients	Experimental	the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities Receives: Device: LAP-BAND® Adjustable Gastric Band (LAGB®)

What is being measured

The primary outcome is the main question the study is designed to answer.

To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.
Measured: 5 years

Secondary outcomes (3)

Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of LDL from baseline at 5 years
Measured: 5 years
Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of Triglycerides from baseline at 5 years
Measured: 5 years
Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of HbA1c from baseline at 5 years
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Sep 2012

First posted24 Dec 2007 (estimated)
Study startMar 2004
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
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: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00580502
Sponsor's protocol ID: H # 10686
Other IDs: 10686, G030190
Acronym: LBMI
Status last verified: Mar 2015
First submitted: 21 Dec 2007
Last updated: 23 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00580502
Acronym / sponsor ID: LBMI / H # 10686
Conditions: Obesity
Keywords: Obesity, 50 lbs overweight
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: Allergan
Study start: Mar 2004
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 24 Dec 2007 (estimated)
Results: Posted 23 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LAGB for low BMI patients	Experimental	Device: LAP-BAND® Adjustable Gastric Band (LAGB®)the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Be at least 18 and equal to or less than 60 years of age.
BMI of at least 30 and maximum BMI of 40 with co-morbidities
Willingness to comply with dietary restrictions required by the protocol
History of obesity for at least 5 years
History of at least 6 months of documented failures with traditional non-surgical weight loss methods

Key exclusion criteria (10 listed)

Age less than 18, age greater than 60
Pregnancy
History of major depressive disorder or psychosis
Previous bariatric surgery or previous gastric surgery
Presence of achalasia

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® Adjustable Gastric Band (LAGB®)Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2	Device	LAGB for low BMI patients

Primary outcome

To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
Time frame: 5 years
Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.

3 secondary outcomes

Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Time frame: 5 years
Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Time frame: 5 years
Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery
Time frame: 5 years

Results and safety

Results posted to the registry on 23 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lap-Band	50	50

Primary outcome: To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery

Time frame: 5 years. Mean (Standard Deviation). Unit: percentage of excess weight loss

Measure	LAGB n = 46
Value	51.74 (27.36)

Population analysed: All participants who underwent LAGB are included in the analysis population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Entire 5 years study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAP-BAND® Adjustable Gastric Band (LAGB®) Operations	14 of 50 (28%)	4 of 50 (8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
NYU Program for Surgical Weight LossLink provided by the sponsor.

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RecruitingObservational study
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Obesity & Overweight, Vitamin D
Recruiting
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Active, not recruiting
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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.

Christine Ren-Fielding, M.D. principal investigator

NYUSOM

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LAP-BAND® Adjustable Gastric Band (LAGB®) in people with Obesity, run by NYU Langone Health.

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 10 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: finished, as of the sponsor's last update on 23 Mar 2015. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00580502.

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 23 Mar 2015.