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

This study has been terminated.
Information provided by (Responsible Party):
Roy Kim, University of Texas Southwestern Medical Center Identifier:
First received: August 2, 2011
Last updated: March 22, 2016
Last verified: March 2016
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
Device: LAP-BAND (Allergan, Inc.)
Phase 2

Study Type: Interventional
Study Design: 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

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

Primary Outcome Measures:
  • body mass index z-score [ Time Frame: 1 year ]

Enrollment: 16
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


Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01409928

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

Responsible Party: Roy Kim, Assistant Professor, University of Texas Southwestern Medical Center Identifier: NCT01409928     History of Changes
Other Study ID Numbers: STU 102010-093
Study First Received: August 2, 2011
Last Updated: March 22, 2016

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

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 28, 2017