Laparoscopic Adjustable Gastric Banding in Adolescents
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ClinicalTrials.gov Identifier: NCT01619488 |
Recruitment Status : Unknown
Verified July 2014 by Kirk Reichard, Nemours Children's Clinic.
Recruitment status was: Active, not recruiting
First Posted : June 14, 2012
Last Update Posted : July 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Morbid Obesity | Device: Adjustable Gastric Band | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents |
Study Start Date : | August 2007 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Gastric Banding
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. |
Device: Adjustable Gastric 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. Other Name: Lap-Band |
- weight loss [ Time Frame: every 6 months for 5 years ]
- The secondary objective is to assess the status of co-morbidities and changes in quality of life scores that occur in adolescents after surgical weight loss. [ Time Frame: followed for 5 years ]

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Ages Eligible for Study: | 14 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ages 14-17
- BMI > 40
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619488
United States, Delaware | |
A I duPont Hospital for Children/Nemours Children's Clinic | |
Wilmington, Delaware, United States, 19803 |
Principal Investigator: | Kirk Reichard, MD | A I duPont Hospital for Children; Nemours Children's Clinic |
Responsible Party: | Kirk Reichard, OR SURGICAL DIRECTOR, Nemours Children's Clinic |
ClinicalTrials.gov Identifier: | NCT01619488 |
Other Study ID Numbers: |
0082295 |
First Posted: | June 14, 2012 Key Record Dates |
Last Update Posted: | July 18, 2014 |
Last Verified: | July 2014 |
Lap-Band morbid obesity adolescents |
Obesity Obesity, Morbid Overnutrition |
Nutrition Disorders Overweight Body Weight |