ESSENTIAL Trial™ Sham Cross-over
Public ClinicalTrials.gov record NCT02279420. 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 Supplemental Open Label Multicenter Sham Cross-over Clinical Trial Using an Endoscopic Suturing Device (g-Cath EZ™ Suture Anchor Delivery Catheter) For Primary Weight Loss Essential Study (IDE G130163) Crossover Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02279420
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 73 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 23 Years to 61 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
- Jan 4, 2015
- Primary completion
- Aug 30, 2016
- Completion
- Sep 29, 2016
- Last update posted
- May 11, 2017
2015 – 2016
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shea Campus -Scottsdale Healthcare | Scottsdale | Arizona | 85258 | — |
| University of Miami Hospital | Miami | Florida | 33166 | — |
| Hamilton Medical Center | Dalton | Georgia | 30720 | — |
| Northshore/Evanston Hospital | Evanston | Illinois | 60201 | — |
| Crescent City Surgical | Metairie | Louisiana | 70001 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Fairview UMMC-University | Minneapolis | Minnesota | 55455 | — |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| WA University School of Medicine | St Louis | Missouri | 63110 | — |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | — |
| Baptist Memorial Hospital | 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 NCT02279420, 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 May 11, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02279420 live on ClinicalTrials.gov.