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NCT01958385 · ClinicalTrials.gov registry record · NA
The USGI Medical ESSENTIAL Study for Weight Loss
A NA study, sponsored by USGI Medical.
- Completed
- Registry status
- NA
- Development phase
- 377
- Enrollment target
NCT01958385: Completed NA study, sponsored by USGI Medical.
NCT01958385 is a NA study that has completed, run by USGI Medical. The registered enrollment target is 377 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01958385, a NA study, has completed, sponsored by USGI Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 377 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.
Primary Outcome
Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.
Interventions
- BEHAVIORAL Diet and Exercise
- PROCEDURE Sham procedure
- DEVICE placement of g-Cath EZ suture anchors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2013-12-01 |
| Est. Completion | 2016-08-01 |
| Phase | NA |
What the finished NCT01958385 record still lists
NCT01958385 is an interventional study that assigns participants to a tested intervention. The registered 377 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 (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Diet and Exercise is the first listed.
NCT01958385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01958385 about?
NCT01958385 is a clinical study titled "The USGI Medical ESSENTIAL Study for Weight Loss". This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure fo...
What is the current status of trial NCT01958385?
This trial is currently completed. It is a NA study. The enrollment target is 377 participants. The study started on 2013-12-01. Estimated completion is 2016-08-01.
What interventions are being tested in trial NCT01958385?
The interventions under investigation include: Diet and Exercise (BEHAVIORAL), Sham procedure (PROCEDURE), placement of g-Cath EZ suture anchors (DEVICE).
Who is sponsoring clinical trial NCT01958385?
This trial is sponsored by USGI Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01958385's enrollment target sits among peer trials
377 274th of 2000 higher than 1,727 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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