A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients

This study is currently recruiting participants.
Verified April 2012 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Roy Kim, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01409928
First received: August 2, 2011
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

This is a prospective, non-randomized, single center study of a laparoscopically placed, adjustable gastric band medical device for the treatment of adolescent obesity.


Condition Intervention Phase
Obesity
Device: LAP-BAND (Allergan, Inc.)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • body mass index z-score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lap-Band Device: LAP-BAND (Allergan, Inc.)
Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Other Name: Lap-Band Adjustable Gastric Banding System

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >= 35 kg/m2 and at least one serious comorbidity (type 2 diabetes mellitus, moderate or severe obstructive sleep apnea, pseudotumor cerebri, and severe steatohepatitis)
  • BMI => 40 kg/m2 and a serious comorbidity (as listed above or at least one other comorbidity (mild obstructive sleep apnea, hypertension, insulin resistance, glucose intolerance, dyslipidemia, impaired quality of life or activities of daily living)
  • Must live in Dallas/Fort Worth area so that necessary follow-up can be ensured.

Exclusion Criteria:

  • Intention to have another surgical procedure for weight reduction within 12 months of LAP-BAND® placement
  • History of pregnancy, or the intention to become pregnant within the next 12 months
  • History of substance abuse within one year prior to surgery
  • Obesity caused by medically correctable condition
  • History of gastric or esophageal surgery, or the presence of an esophageal dysmotility disorder
  • Eating disorder that is untreated
  • Chronic use of aspirin and/or nonsteroidal anti-inflammatory medications and unwillingness to discontinue the use of these medications
  • History of previous bariatric surgery, intestinal obstruction, or peritonitis
  • Presence of localized or systemic infection at the time of surgery
  • History of congenital or acquired anomalies of the gastrointestinal tract
  • History of immunocompromise, or auto-immune, hematologic or dermatologic condition that increases risk of bleeding, breakdown of skin integrity (due to port), or infection.
  • Planning to or having high likelihood of moving out of region within 2 years
  • Portal Hypertension or Cirrhosis
  • Uncorrectable coagulopathy or severe bleeding disorder
  • Use of weight loss medications within 6 weeks of procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409928

Contacts
Contact: Roy Kim, MD 214-648-3501 roy.kim@utsouthwestern.edu

Locations
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Roy Kim, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01409928     History of Changes
Other Study ID Numbers: STU 102010-093
Study First Received: August 2, 2011
Last Updated: April 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
obesity
adolescent
pediatric
weight loss
bariatric surgery
gastric banding

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

ClinicalTrials.gov processed this record on April 16, 2014