View Clinical Trial (Medical Research Study)
A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients
| City: |
|
Dallas |
| State: |
|
Texas |
| Zip Code: |
|
75390 |
| Conditions: |
|
Obesity |
| 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.
|
| Study Summary: |
|
|
| 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
|
| NCT ID: |
|
NCT01409928 |
| Primary Contact: |
|
Roy Kim, MD
Phone: 214-648-3501
Email: roy.kim@utsouthwestern.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Dallas, Texas 75390
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|