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Laparascopic Adjustable Gastric Banding in Adolescents

This study is currently recruiting participants.
Verified June 2012 by Nemours Children's Clinic
Sponsor:
Information provided by (Responsible Party):
Kirk Reichard, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01619488
First received: June 7, 2012
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Morbid Obesity
 Device: Adjustable Gastric Band
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparascopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • weight loss [ Time Frame: every 6 months for 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: August 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619488

Contacts
Contact: Kirk Reichard, MD 302-651-4730

Locations
United States, Delaware
A I duPont Hospital for Children/Nemours Children's Clinic Recruiting
Wilmington, Delaware, United States, 19803
Contact: George Datto, MD     302-651-4730        
Principal Investigator: Kirk Reichard, MD            
Sponsors and Collaborators
Kirk Reichard
Investigators
Principal Investigator: Kirk Reichard, MD A I duPont Hospital for Children; Nemours Children's Clinic
  More Information

No publications provided

Responsible Party: Kirk Reichard, OR SURGICAL DIRECTOR, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01619488     History of Changes
Other Study ID Numbers: 0082295
Study First Received: June 7, 2012
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nemours Children's Clinic:
Lap-Band
morbid obesity
adolescents

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013