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NCT01980758 · ClinicalTrials.gov registry record · NA
Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
A NA study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT01980758 is a NA study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 4 participants.
The verdict
NCT01980758, a NA study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
The proposed study aims to investigate the effects of laparoscopic gastric plication (LGP) on excess body weight, body mass index, and weight-related medical and psychological co-morbidities in obese adolescents. Additionally, we will evaluate the safety and efficacy of this procedure (implemented within a multidisciplinary comprehensive lifestyle modification program) on changes in the patients' medical status, psychosocial and psychological functioning, physical fitness, and health-related quality of life. Study hypothesis: 1. Laparoscopic gastric plication performed on carefully selected obese adolescents within a multidisciplinary treatment program providing pre and post-surgical behavioral and psychological support and education will result in: a) initial and sustained reductions in excess body weight and body mass index, b) improvements in psychological functioning, physical fitness, and health-related quality of life, and c) reduction in weight-related comorbidities. 2. LGP will be a safe procedure, with complication rates that are comparable to or lower than what has been found in other published reports of surgical weight loss procedures used in obese adolescents.
Interventions
- PROCEDURE Laparoscopic Gastric Plication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-05 |
| Est. Completion | 2018-03-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01980758
The ClinicalTrials.gov registry entry for NCT01980758 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Laparoscopic Gastric Plication is the first listed.
NCT01980758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01980758 about?
NCT01980758 is a clinical study titled "Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity". The proposed study aims to investigate the effects of laparoscopic gastric plication (LGP) on excess body weight, body mass index, and weight-related medical and psychological co-morbidities in obese adolescents. Additionally, we will evaluate the safety and efficacy of this procedure (implemented w...
What is the current status of trial NCT01980758?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2013-05. Estimated completion is 2018-03-08.
What interventions are being tested in trial NCT01980758?
The interventions under investigation include: Laparoscopic Gastric Plication (PROCEDURE).
Who is sponsoring clinical trial NCT01980758?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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