Morbid ObesityNCT00447590
Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
A study testing LAP-BAND System in people with Morbid Obesity, run by Apollo Endosurgery, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- LAP-BAND System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jun 2013
- 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
- Between the ages of 14 and 17 at the time of enrollment
- Have a BMI ≥ 40 kg/m2 (with or without obesity-related co-morbid conditions) or BMI ≥ 35 kg/m2 with one or more severe co-morbid conditions
- Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs
Who cannot join
- Family or subject history of congenital or acquired anomalies of the gastrointestinal tract
- Severe cardiopulmonary or other serious or uncontrolled organic disease
- Severe coagulopathy; hepatic insufficiency or cirrhosis
- History of bariatric, gastric, or esophageal surgery
- History of intestinal obstruction or adhesive peritonitis
- History of esophageal dysmotility disorders
- Type I diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Read the detailed description
The primary objective of this study was to evaluate the safety and effectiveness of the LAP-BAND System in a morbidly obese adolescent population, ages 14 to 17 years. The secondary objectives were to assess associated changes from baseline in obesity-related comorbidities as well as psychosocial functioning.
- Conditions
- Morbid Obesity
- Being tested
- LAP-BAND System
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAP-BAND SystemDevice
Restriction of food intake
| Study group | Role | What they receive |
|---|---|---|
| LAP-BAND | Experimental | All subjects who received the LAP-BAND System. Receives: Device: LAP-BAND System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.
Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.
Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years.
Measured: 1 year
Secondary outcomes (5)
Subject Excess Weight Loss Throughout the Study
Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.
Measured: Baseline to 5 Years
Subject Percent Excess BMI Loss
Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.
Measured: Baseline to 5 Years
Change in Subjects' Comorbid Conditions
The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved.
Measured: Baseline to 5 Years
Change in Quality of Life Using the Beck Depression Inventory II (BDI)
Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years.
Measured: Baseline to 5 Years
Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire
Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years.
Measured: Baseline to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2009
- Study completionJun 2013
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 Morbid ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Endosurgery, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Apollo Endosurgery, Study director, Apollo Endosurgery, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447590
- Sponsor's protocol ID
- LBA-001
- Status last verified
- Sep 2014
- First submitted
- 14 Mar 2007
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
- ClinicalTrials.gov ID
- NCT00447590
- Acronym / sponsor ID
- LBA-001
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Apollo Endosurgery, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Mar 2007 (estimated)
- Results
- Posted 23 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Detailed description
The primary objective of this study was to evaluate the safety and effectiveness of the LAP-BAND System in a morbidly obese adolescent population, ages 14 to 17 years. The secondary objectives were to assess associated changes from baseline in obesity-related comorbidities as well as psychosocial functioning.
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-BAND SystemAll subjects who received the LAP-BAND System. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between the ages of 14 and 17 at the time of enrollment
- Have a BMI ≥ 40 kg/m2 (with or without obesity-related co-morbid conditions) or BMI ≥ 35 kg/m2 with one or more severe co-morbid conditions
- Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs
Key exclusion criteria (7 listed)
- Family or subject history of congenital or acquired anomalies of the gastrointestinal tract
- Severe cardiopulmonary or other serious or uncontrolled organic disease
- Severe coagulopathy; hepatic insufficiency or cirrhosis
- History of bariatric, gastric, or esophageal surgery
- History of intestinal obstruction or adhesive peritonitis
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 SystemRestriction of food intake | Device | LAP-BAND |
Primary outcome
Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.
Time frame: 1 year
Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years.
5 secondary outcomes
Subject Excess Weight Loss Throughout the Study
Time frame: Baseline to 5 Years
Subject Percent Excess BMI Loss
Time frame: Baseline to 5 Years
Change in Subjects' Comorbid Conditions
Time frame: Baseline to 5 Years
Change in Quality of Life Using the Beck Depression Inventory II (BDI)
Time frame: Baseline to 5 Years
Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire
Time frame: Baseline to 5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Apollo Endosurgery study director
Apollo Endosurgery, Inc.
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 System in people with Morbid Obesity, run by Apollo Endosurgery, Inc. 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 3 inclusion and 7 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 2 Oct 2014. 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 23 Sep 2014). 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?
Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. (time frame: 1 year). 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 2 Oct 2014.