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

June 7, 2012
June 12, 2012
August 2007
December 2013   (final data collection date for primary outcome measure)
weight loss [ Time Frame: every 6 months for 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01619488 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Laparascopic Adjustable Gastric Banding in Adolescents
Laparascopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Morbid Obesity
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
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.

Intervention: Device: Adjustable Gastric Band
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
December 2018
December 2013   (final data collection date for primary outcome measure)

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
Both
14 Years to 17 Years
No
Contact: Kirk Reichard, MD 302-651-4730
United States
 
NCT01619488
0082295
Yes
Kirk Reichard, Nemours Children's Clinic
Kirk Reichard
Not Provided
Principal Investigator: Kirk Reichard, MD A I duPont Hospital for Children; Nemours Children's Clinic
Nemours Children's Clinic
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP