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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

Tracking Information
First Submitted Date  ICMJE June 7, 2012
First Posted Date  ICMJE June 14, 2012
Last Update Posted Date July 18, 2014
Study Start Date  ICMJE August 2007
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
weight loss [ Time Frame: every 6 months for 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Adjustable Gastric Banding in Adolescents
Official Title  ICMJE Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents
Brief Summary This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01619488
Other Study ID Numbers  ICMJE 0082295
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirk Reichard, Nemours Children's Clinic
Study Sponsor  ICMJE Kirk Reichard
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kirk Reichard, MD A I duPont Hospital for Children; Nemours Children's Clinic
PRS Account Nemours Children's Clinic
Verification Date July 2014

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