Morbid ObesityNCT01619488
Laparoscopic Adjustable Gastric Banding in Adolescents
A study testing Adjustable Gastric Band in people with Morbid Obesity, run by Kirk Reichard at 1 site in United States.
Trial summary
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Adjustable Gastric Band
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2007to 4 Apr 2016
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ages 14-19
- BMI > 35
- history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
- confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.
Who cannot join
- history of congenital or acquired anomalies of the GI tract.
- history of esophageal motility disorders
- uncontrolled psychiatric problems
- previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
- uncontrolled eating disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
A I duPont Hospital for Children/Nemours Children's Clinic
Wilmington, Delaware, 19803
About this study
Official title: Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Read the detailed description
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents
- Conditions
- Morbid Obesity
- Being tested
- Adjustable Gastric Band
- Keywords
- Lap-Band, morbid obesity, adolescents
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable Gastric BandDevice
Also called Lap-Band
Surgical placement of an adjustable gastric band around the upper portion of the stomach.
Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Banding | Experimental | Surgical placement of an adjustable gastric band around the upper portion of the stomach.
Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. Receives: Device: Adjustable Gastric Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weight Loss
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
Measured: Up to five years post surgery.
Secondary outcomes (1)
Insulin Resistance
Fasting insulin level
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study start23 Apr 2007
- Primary completion4 Apr 2016
- Study completion4 Apr 2016
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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirk Reichard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirk Reichard, Nemours Children's Clinic
- Investigators
- Kirk Reichard, MD, Principal investigator, A I duPont Hospital for Children; Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619488
- Sponsor's protocol ID
- 0082295
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2012
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents
- ClinicalTrials.gov ID
- NCT01619488
- Acronym / sponsor ID
- 0082295
- Conditions
- Morbid Obesity
- Keywords
- Lap-Band, morbid obesity, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kirk ReichardUniversity, hospital or other
- Study start
- 23 Apr 2007 (actual)
- Primary completion
- 4 Apr 2016 (actual)
- Study completion
- 4 Apr 2016 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Posted 8 Jun 2023
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 determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Detailed description
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Banding | Experimental | Device: Adjustable Gastric BandSurgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- ages 14-19
- BMI > 35
- history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
- confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.
Key exclusion criteria (5 listed)
- history of congenital or acquired anomalies of the GI tract.
- history of esophageal motility disorders
- uncontrolled psychiatric problems
- previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
- uncontrolled eating disorders
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 |
|---|---|---|
| Adjustable Gastric BandAlso: Lap-BandSurgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. | Device | Gastric Banding |
Primary outcome
Total Weight Loss
Time frame: Up to five years post surgery.
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
1 secondary outcome
Insulin Resistance
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kirk Reichard, MD principal investigator
A I duPont Hospital for Children; Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable Gastric Band in people with Morbid Obesity, run by Kirk Reichard 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 4 inclusion and 5 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 1 Aug 2023. 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 8 Jun 2023). 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?
Total Weight Loss (time frame: Up to five years post surgery.). 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 1 Aug 2023.