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NCT01703546 · ClinicalTrials.gov registry record · NA
Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
A NA study, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 420
- Enrollment target
NCT01703546: Completed NA study, sponsored by Northwell Health.
NCT01703546 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 420 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01703546, a NA study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 420 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.
Primary Outcome
Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EW
Interventions
- PROCEDURE LAGB & LGCP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-11 |
| Phase | NA |
What the finished NCT01703546 record still lists
NCT01703546 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which LAGB & LGCP is the first listed.
NCT01703546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01703546 about?
NCT01703546 is a clinical study titled "Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication". The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess w...
What is the current status of trial NCT01703546?
This trial is currently completed. It is a NA study. The enrollment target is 420 participants. The study started on 2011-11. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01703546?
The interventions under investigation include: LAGB & LGCP (PROCEDURE).
Who is sponsoring clinical trial NCT01703546?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01703546's enrollment target sits among peer trials
420 239th of 2000 higher than 1,761 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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