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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 is a NA study that has completed, run by USGI Medical. The registered enrollment target is 377 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01958385
The ClinicalTrials.gov registry entry for NCT01958385 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 377 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is USGI Medical, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Diet and Exercise is the first listed.
NCT01958385 reports 0 study locations.
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.
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