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Laparoscopic Adjustable Gastric Banding in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Kirk Reichard, Nemours Children's Clinic

Study Description
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Brief Summary:
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: Adjustable Gastric Band Phase 3

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. weight loss [ Time Frame: every 6 months for 5 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Delaware
A I duPont Hospital for Children/Nemours Children's Clinic
Wilmington, Delaware, United States, 19803
Sponsors and Collaborators
Kirk Reichard
Investigators
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Principal Investigator: Kirk Reichard, MD A I duPont Hospital for Children; Nemours Children's Clinic
More Information
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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
Keywords provided by Kirk Reichard, Nemours Children's Clinic:
Lap-Band
morbid obesity
adolescents
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
 Nutrition Disorders
Overweight
Body Weight