Trial Outcomes & Findings for ESSENTIAL Trial™ Sham Cross-over (NCT NCT02279420)

Results Overview

Percent total body weight loss calculated through 12 months post procedure

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

1 Year

Results posted on

2017-05-12

Participant milestones
Measure	Essential Study Sham Cross-over Eligible sham subjects from primary study
Overall Study STARTED	73
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	23

Reasons for withdrawal
Measure	Essential Study Sham Cross-over Eligible sham subjects from primary study
Overall Study Lost to Follow-up	23

ESSENTIAL Trial™ Sham Cross-over

Baseline characteristics by cohort
Measure	Essential Study Sham Cross-over n=73 Participants Device: g-Cath EZ™ Suture Anchor Delivery Catheter 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.
Age, Continuous	45.2 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	73 Participants n=5 Participants

Timeframe: 1 Year

Percent total body weight loss calculated through 12 months post procedure

Outcome measures
Measure	Essential Study Sham Cross-over n=50 Participants 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.
Mean Percent Total Body Weight Loss	5.7 percentage of TBW Standard Deviation 6

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	Essential Study Sham Cross-over n=73 participants at risk 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.
General disorders Dehydration	2.7% 2/73 • Number of events 2
Gastrointestinal disorders Nausea	1.4% 1/73 • Number of events 1

Other adverse events
Measure	Essential Study Sham Cross-over n=73 participants at risk 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.
Renal and urinary disorders Kidney Infection	2.7% 2/73 • Number of events 2

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