ObesityALAGBNCT00587301
Lap-Band Surgery on Adolescents for Safety and Efficacy
A study testing Lap-Band in people with Obesity and DM, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- What is being tested?
- Lap-Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to 8 Jul 2020
- Phase
- Interventional
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be at least 14 and less than 18 years of age at the time of enrollment into the study.
- Have a BMI of at least 40
- Have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity.
- Confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol.
- Express willingness to follow protocol requirements.
- •Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception.
Who cannot join
- Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement.
- History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulopathy; hepatic insufficiency or cirrhosis.
- Presence of dysphagia or documented esophageal dysmotility.
- Patients with autoimmune connective tissue disorders
- Patients with acute abdominal infections
- Pregnancy or intention of becoming pregnant in the next 12 months.
Show all 12Show fewer
- Presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol.
- History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis.
- Presence of localized or systemic infection at the time of surgery.
- Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications.
- History of gastric or esophageal surgery.
- Use of weigh loss medications simultaneously
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17)
This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
Read the detailed description
STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss.
STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).
DESIGN:Prospective, open-label, and single center
- Being tested
- Lap-Band
- Keywords
- Child Obesity
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lap-BandDevice
Also called Lap-Band Adjustable Gastric Band (LAGB) Operation
Obesity and adolescents
| Study group | Role | What they receive |
|---|---|---|
| Lap-Band | Experimental | Lap-band surgery in treatment of morbidly obese adolescents Receives: Device: Lap-Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Excess Weight Loss (EWL)
Measured: Year 1
Percentage of Excess Weight Loss (EWL)
Measured: Year 2
Percentage of Excess Weight Loss (EWL)
Measured: Year 3
Percentage of Excess Weight Loss (EWL)
Measured: Year 4
Percentage of Excess Weight Loss (EWL)
Measured: Year 5
Secondary outcomes (5)
Body Mass Index (BMI)
Measured: Year 1
Body Mass Index (BMI)
Measured: Year 2
Body Mass Index (BMI)
Measured: Year 3
Body Mass Index (BMI)
Measured: Year 4
Body Mass Index (BMI)
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJun 2005
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Hope Foundation
- Responsible party
- Sponsor
- Investigators
- Christine Ren-Fielding, M.D., Principal investigator, NYUSOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587301
- Sponsor's protocol ID
- 11876
- Other IDs
- G050010
- Acronym
- ALAGB
- Status last verified
- Mar 2022
- First submitted
- 21 Dec 2007
- Last updated
- 22 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17)
- ClinicalTrials.gov ID
- NCT00587301
- Acronym / sponsor ID
- ALAGB / 11876
- Keywords
- Child Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Hope Foundation
- Study start
- Jun 2005
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 22 Mar 2022
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 demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
Detailed description
STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss.
STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).
DESIGN:Prospective, open-label, and single center
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lap-Band | Experimental | Device: Lap-BandLap-band surgery in treatment of morbidly obese adolescents |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Be at least 14 and less than 18 years of age at the time of enrollment into the study.
- Have a BMI of at least 40
- Have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity.
- Confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol.
- Express willingness to follow protocol requirements.
Key exclusion criteria (12 listed)
- Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement.
- History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulopathy; hepatic insufficiency or cirrhosis.
- Presence of dysphagia or documented esophageal dysmotility.
- Patients with autoimmune connective tissue disorders
- Patients with acute abdominal infections
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-BandAlso: Lap-Band Adjustable Gastric Band (LAGB) OperationObesity and adolescents | Device | Lap-Band |
Primary outcome
Percentage of Excess Weight Loss (EWL)
Time frame: Year 1
Percentage of Excess Weight Loss (EWL)
Time frame: Year 2
Percentage of Excess Weight Loss (EWL)
Time frame: Year 3
Percentage of Excess Weight Loss (EWL)
Time frame: Year 4
Percentage of Excess Weight Loss (EWL)
Time frame: Year 5
5 secondary outcomes
Body Mass Index (BMI)
Time frame: Year 1
Body Mass Index (BMI)
Time frame: Year 2
Body Mass Index (BMI)
Time frame: Year 3
Body Mass Index (BMI)
Time frame: Year 4
Body Mass Index (BMI)
Time frame: Year 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NYU Program for Surgical Weight LossLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lap-Band in people with Obesity and DM, run by NYU Langone Health at 1 site in United States.
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 6 inclusion and 12 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 22 Mar 2022). 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?
Percentage of Excess Weight Loss (EWL) (time frame: Year 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 22 Mar 2022.