Status:
TERMINATED
A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Obesity
Eligibility:
All Genders
14-17 years
Phase:
NA
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.
Detailed Description
Study population We plan to enroll 30 subjects between the ages of 14 and 17 years with the LAP-BAND®. The inclusion criteria are in accordance with recent evidence-based indications for the surgical ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01409928
Start Date
March 1 2012
End Date
March 21 2016
Last Update
April 7 2020
Active Locations (1)
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1
Children's Medical Center Dallas
Dallas, Texas, United States, 75390