OBESITYNCT01882049
Use of Adjustable Gastric Band in Adolescents
A study testing REALIZE Gastric band (ETHICON) in people with OBESITY, run by University of Minnesota at 1 site in United States.
Trial summary
This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- OBESITY
- What is being tested?
- REALIZE Gastric band (ETHICON)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2016
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5
Who cannot join
- •Hypertension: Systolic blood pressure (SBP) of 140 mm Hg
- Hyperlipidemia: hyperlipidemia depends on
- Obstructive Sleep Apnea:
- Metabolic Syndrom: The presence of any three of the following: abdominal obesity - dimensons for children? triglycerides -cholesterol -
- fasting glucose
- blood pressure
Show all 11Show fewer
- overweight
- Non-surgical means of weight reduction failure of
- Significant psychopathology (absence of ) that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, as documented during screening assessment;
- Agrees to refrain from any type of reconstructive surgery that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for three years following SAGB placement; and
- Candidate for surgical weight loss intervention (i.e., meets accepted health criteria for major surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Use of the REALIZE™ Adjustable Gastric Band (Model 2200-X) in Adolescents
This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.
Read the detailed description
Weight loss is related to the amount of energy or fuel obtained from the kinds and amounts of food eaten. When the amount of exercise and dieting uses less fuel than the amount taken in, the excess is stored as fat. The Adjustable Gastric Band used in this study is a tool to help the participant loose weight along with healthy eating, diet and exercise. This study involves minimally invasive laparoscopic surgery to place the adjustable band around the upper part of the stomach to make a smaller stomach or pouch about the size of a golf ball. One end of the band ends with a flat balloon that goes around the upper part of the stomach. The opening from this small stomach can be changed to allow more or less food into the intestine depending on the amount eaten and the amount of weight lost.
The other end of the of the band ends in a filling port through which saline solution is pumped with a needle through an attached tube to inflate or deflate the balloon. The filling port is attached to the wall of the abdomen under the skin. Because the flow of food is regulated by the band, most people feel full faster. This is how the appetite for food is controlled and the why the person is likely to eat less with the band in place.
Food is digested through the normal digestive process.
- Conditions
- OBESITY
- Being tested
- REALIZE Gastric band (ETHICON)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REALIZE Gastric band (ETHICON)Device
Placement of gastric band around upper stomach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Use of Realize gastric band (Ethicon) in adolescents for weight reduction Receives: Device: REALIZE Gastric band (ETHICON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Reduction in percent of excess weight loss (%EWL).
Measured: Monthly up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: study never started due to funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OBESITYStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sayeed Ikrammudin, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882049
- Sponsor's protocol ID
- IDE#G100290
- Status last verified
- May 2016
- First submitted
- 20 Nov 2012
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the REALIZE™ Adjustable Gastric Band (Model 2200-X) in Adolescents
- ClinicalTrials.gov ID
- NCT01882049
- Acronym / sponsor ID
- IDE#G100290
- Conditions
- OBESITY
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never started due to funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Jun 2013 (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.
This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.
Detailed description
Weight loss is related to the amount of energy or fuel obtained from the kinds and amounts of food eaten. When the amount of exercise and dieting uses less fuel than the amount taken in, the excess is stored as fat. The Adjustable Gastric Band used in this study is a tool to help the participant loose weight along with healthy eating, diet and exercise. This study involves minimally invasive laparoscopic surgery to place the adjustable band around the upper part of the stomach to make a smaller stomach or pouch about the size of a golf ball. One end of the band ends with a flat balloon that goes around the upper part of the stomach. The opening from this small stomach can be changed to allow more or less food into the intestine depending on the amount eaten and the amount of weight lost.
The other end of the of the band ends in a filling port through which saline solution is pumped with a needle through an attached tube to inflate or deflate the balloon. The filling port is attached to the wall of the abdomen under the skin. Because the flow of food is regulated by the band, most people feel full faster. This is how the appetite for food is controlled and the why the person is likely to eat less with the band in place.
Food is digested through the normal digestive process.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: REALIZE Gastric band (ETHICON)Use of Realize gastric band (Ethicon) in adolescents for weight reduction |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5
Key exclusion criteria (11 listed)
- •Hypertension: Systolic blood pressure (SBP) of 140 mm Hg
- fasting glucose
- blood pressure
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 |
|---|---|---|
| REALIZE Gastric band (ETHICON)Placement of gastric band around upper stomach | Device | Treatment |
Primary outcome
Weight loss
Time frame: Monthly up to one year
Reduction in percent of excess weight loss (%EWL).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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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.
Sayeed Ikrammudin, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REALIZE Gastric band (ETHICON) in people with OBESITY, run by University of Minnesota 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 1 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 May 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Weight loss (time frame: Monthly up to one 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 16 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.