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:
University of Texas Southwestern Medical Center
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
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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 May 16, 2013