An interventional study of Adjustable Gastric Band in Morbid Obesity, sponsored by Kirk Reichard. Completed at 1 site in United States. Open to participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Kirk Reichard · Not applicable, Interventional, and Treatment
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents
936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.
This study's enrollment of 57 is close to the median of 60 across 599 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →This is the only study on the registry with Kirk Reichard as lead sponsor.
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Exclusion Criteria:
Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Device: Adjustable Gastric Band
Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Also known as: Lap-Band
Total Weight Loss
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
Time frame: Up to five years post surgery.
Insulin Resistance
Fasting insulin level
Time frame: Baseline
Eligible patients were recruited from the pediatric weight management clinic.
| Milestone | Gastric Banding |
|---|---|
| Started | 57 |
| Completed | 57 |
| Not completed | 0 |
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
| kilograms | Weight Loss |
|---|---|
| Total Weight Loss | 11.35 ± 19.08 |
Fasting insulin level
| uIU/ml | Fasting Serum Insulin Change |
|---|---|
| Insulin Resistance | 12.5 ± 14.0 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events | 0/57 (0%) | 2/57 (3.5%) | 0/57 (0%) |
| Event | Adverse Events |
|---|---|
| Band slippage, leading to removalGastrointestinal disorders | 2/57 |
| Age, Categorical(Participants) | Gastric Band |
|---|---|
| <=18 years | 56 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Age, Continuous(years) | Gastric Band |
|---|---|
| Mean | 16.05 ± 1.22 |
| Sex: Female, Male(Participants) | Gastric Band |
|---|---|
| Female | 48 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Gastric Band |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 16 |
| White | 37 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Gastric Band |
|---|---|
| United States | 57 |
| Weight(Kilogram) | Gastric Band |
|---|---|
| Mean | 139.36 ± 19.7 |
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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