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

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ClinicalTrials.gov Identifier: NCT01409928
Recruitment Status : Terminated
First Posted : August 4, 2011
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Roy Kim, University of Texas Southwestern Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Device: LAP-BAND (Allergan, Inc.) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients
Study Start Date : March 2012
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409928


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

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
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Roy Kim, 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