The USGI Medical ESSENTIAL Study for Weight Loss
Public ClinicalTrials.gov record NCT01958385. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01958385
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 377 participants
Conditions and interventions
Conditions
Interventions
- placement of g-Cath EZ suture anchors Device
- Sham procedure Procedure
- Diet and Exercise Behavioral
Device · Procedure · Behavioral
Eligibility (public fields only)
- Age range
- 22 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2013
- Primary completion
- Apr 30, 2015
- Completion
- Jul 31, 2016
- Last update posted
- Apr 3, 2017
2013 – 2016
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85258 | — |
| DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine | Miami | Florida | 33166 | — |
| Hamilton Medical Center | Dalton | Georgia | 30722 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| Crescent City Surgical Centre | Covington | Louisiana | 70433 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02120 | — |
| University of MN, Fairview Health Services | Minneapolis | Minnesota | 55455 | — |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | — |
| Baptist Memorial | Memphis | Tennessee | 38120 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01958385, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 3, 2017 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01958385 live on ClinicalTrials.gov.