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NCT02279420 · ClinicalTrials.gov registry record · NA
ESSENTIAL Trial™ Sham Cross-over
A NA study of Obesity, sponsored by USGI Medical.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
- 11
- Study locations
NCT02279420: Completed NA study of Obesity, sponsored by USGI Medical.
NCT02279420 is a NA study of Obesity that has completed, run by USGI Medical. The registered enrollment target is 73 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (91% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02279420, a NA study of Obesity, has completed, sponsored by USGI Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
Primary Outcome
Percent total body weight loss calculated through 12 months post procedure
Conditions Studied
Interventions
- DEVICE g-Cath EZ™ Suture Anchor Delivery Catheter
Study Locations (11)
Missouri
- Saint Luke's Hospital - Kansas City
- WA University School of Medicine - St Louis
Arizona
- Shea Campus -Scottsdale Healthcare - Scottsdale
Florida
- University of Miami Hospital - Miami
Georgia
- Hamilton Medical Center - Dalton
Illinois
- Northshore/Evanston Hospital - Evanston
Louisiana
- Crescent City Surgical - Metairie
Massachusetts
- Brigham & Women's Hospital - Boston
Minnesota
- Fairview UMMC-University - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2015-01-05 |
| Est. Completion | 2016-09-30 |
| Phase | NA |
What the finished NCT02279420 record still lists
NCT02279420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which g-Cath EZ™ Suture Anchor Delivery Catheter is the first listed.
NCT02279420 lists 11 locations in 10 states (Missouri, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT02279420 about?
NCT02279420 is a clinical study titled "ESSENTIAL Trial™ Sham Cross-over". This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and e...
What is the current status of trial NCT02279420?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2015-01-05. Estimated completion is 2016-09-30.
What conditions does trial NCT02279420 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT02279420?
The interventions under investigation include: g-Cath EZ™ Suture Anchor Delivery Catheter (DEVICE).
Who is sponsoring clinical trial NCT02279420?
This trial is sponsored by USGI Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02279420 being conducted?
This trial has 11 study locations across Arizona, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02279420's enrollment target sits among peer trials
73 576th of 1053 higher than 472 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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