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Laparoscopic Adjustable Gastric Banding in Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kirk Reichard, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01619488
First received: June 7, 2012
Last updated: July 17, 2014
Last verified: July 2014
  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: Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents

Resource links provided by NLM:


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: May 2018 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619488

Locations
United States, Delaware
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
  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: July 17, 2014
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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014