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NCT01077193 · ClinicalTrials.gov registry record · NA
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
A NA study, sponsored by Ethicon Endo-Surgery.
- Terminated
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT01077193: Clinical Trial NA study, sponsored by Ethicon Endo-Surgery.
NCT01077193 is a NA study that was terminated before completion, run by Ethicon Endo-Surgery. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01077193, a NA study, was terminated before completion, sponsored by Ethicon Endo-Surgery.
- TERMINATED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
Primary Outcome
Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss
Interventions
- PROCEDURE Gastric Plication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-05 |
| Phase | NA |
Why NCT01077193 stopped before completion
NCT01077193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Gastric Plication is the first listed.
NCT01077193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01077193 about?
NCT01077193 is a clinical study titled "Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication". Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
What is the current status of trial NCT01077193?
This trial is currently terminated. It is a NA study. The enrollment target is 44 participants. The study started on 2009-11. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01077193?
The interventions under investigation include: Gastric Plication (PROCEDURE).
Who is sponsoring clinical trial NCT01077193?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01077193's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 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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