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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: Completed NA study, sponsored by Virginia Commonwealth University.

NCT01980758 is a NA study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 4 participants
Start Date 2013-05
Est. Completion 2018-03-08
Phase NA
Virginia Commonwealth University

558 total trials

What the finished NCT01980758 record still lists

NCT01980758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Laparoscopic Gastric Plication is the first listed.

NCT01980758 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01980758's enrollment target sits among peer trials

4 1996th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01980758, the US trial registry maintained by the National Library of Medicine. NCT01980758 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.