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Laparoscopic Adjustable Gastric Banding in Adolescents

Sponsor
Kirk Reichard (Other)
Overall Status
Unknown status
CT.gov ID
NCT01619488
Collaborator
(none)
75
Enrollment
1
Location
1
Arm
136
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Adjustable Gastric Band
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2007
Anticipated Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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 Names:
  • Lap-Band

    		•

    Outcome Measures

    Primary Outcome Measures

    1. weight loss [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. [followed for 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 17 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A I duPont Hospital for Children/Nemours Children's Clinic Wilmington Delaware United States 19803

    Sponsors and Collaborators

    • Kirk Reichard

    Investigators

    • Principal Investigator: Kirk Reichard, MD, A I duPont Hospital for Children; Nemours Children's Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kirk Reichard, OR SURGICAL DIRECTOR, Nemours Children's Clinic
    ClinicalTrials.gov Identifier:
    NCT01619488
    Other Study ID Numbers:
    • 0082295
    First Posted:
    Jun 14, 2012
    Last Update Posted:
    Jul 18, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Kirk Reichard, OR SURGICAL DIRECTOR, Nemours Children's Clinic
    Lap-Band
    morbid obesity
    adolescents
    Additional relevant MeSH terms:
    Obesity
    Obesity, Morbid

    Study Results

    No Results Posted as of Jul 18, 2014