NCT02279420

ESSENTIAL Trial™ Sham Cross-over

Completed NA Results posted Last updated 12 May 2017

What this trial tests

NA trial testing g-Cath EZ™ Suture Anchor Delivery Catheter in Obesity in 73 participants. Completed in 30 September 2016.

Timeline

5 January 2015

Primary endpoint
31 August 2016

30 September 2016

Quick facts

Lead sponsor	USGI Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	5 January 2015
Primary completion	31 August 2016
Estimated completion	30 September 2016
Sites	11 locations across United States

Drugs / interventions tested

• g-Cath EZ™ Suture Anchor Delivery Catheter

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

USGI Medical

Who can join

Adults 23 to 61, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Percent Total Body Weight Loss Primary · 1 Year

Percent total body weight loss calculated through 12 months post procedure

Group	Value	95% CI
Essential Study Sham Cross-over	5.7	± 6

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Essential Study Sham Cross-over

Serious: 3/73 (4%)

Deaths: 0/73

Serious adverse events (2 terms)

Reaction	System	Essential Study Sham Cross…
Dehydration	General disorders	—
Nausea	Gastrointestinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Essential Study Sham Cross…
Kidney Infection	Renal and urinary disorders	—

Most-reported serious reactions: Dehydration, Nausea.

Data from ClinicalTrials.gov NCT02279420 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.