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Laparoscopic Adjustable Gastric Banding in Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619488
First Posted: June 14, 2012
Last Update Posted: July 18, 2014
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.
Information provided by (Responsible Party):
Kirk Reichard, Nemours Children's Clinic
June 7, 2012
June 14, 2012
July 18, 2014
August 2007
May 2018   (Final data collection date for primary outcome measure)
weight loss [ Time Frame: every 6 months for 5 years ]
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 ]
Same as current
Not Provided
Not Provided
 
Laparoscopic Adjustable Gastric Banding in Adolescents
Laparoscopic 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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Active, not recruiting
75
December 2018
May 2018   (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
Sexes Eligible for Study: All
14 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01619488
0082295
Yes
Not Provided
Not Provided
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
July 2014

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