Trial Outcomes & Findings for Hernia Reduction Prior to Scheduled TIF Completion (NCT NCT03280121)

Last Updated: 2021-02-10

Results Overview

Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH \< 4 in

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

48 hour monitoring period

Results posted on

2021-02-10

Participant Flow

There were two sites that recruited patients. One was in Iron Mountain. Michigan and one in Sparks, Nevada. The procedures were done in hospitals. The recruitment was from August 18 2018 through February 2019. The study was closed by the sponsor due to slow enrollment.

Participant milestones

Participant milestones
Measure	TIF Using EsophyX ZR Transoral Device Prospective, investigator initiated, multicenter, non-randomized single arm, open label
Overall Study STARTED	14
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	TIF Using EsophyX ZR Transoral Device Prospective, investigator initiated, multicenter, non-randomized single arm, open label
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	1
Overall Study screen failure - 3 hernia too small and 1 pH too low	4

Baseline Characteristics

Hernia Reduction Prior to Scheduled TIF Completion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIF Using EsophyX ZR Transoral Device n=14 Participants Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device EsophyX ZR transoral device: TIF
Age, Continuous	62 years n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants

PRIMARY outcome

Timeframe: 48 hour monitoring period

Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH \< 4 in

Outcome measures

Outcome measures
Measure	TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) n=8 Participants Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device EsophyX ZR transoral device: TIF
pH Study	6 Participants

SECONDARY outcome

Timeframe: 6 months

Population: The relatively small number of patients that were willing to come back for follow-up and assessment of outcome measure.

Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week

Outcome measures

Outcome measures
Measure	TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) n=3 Participants Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device EsophyX ZR transoral device: TIF
Number of Participants With a Change in Troublesome Symptoms From Baseline	3 Participants

SECONDARY outcome

Timeframe: 6 months

from daily use to occasional use or none at all.

Outcome measures

Outcome measures
Measure	TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) n=8 Participants Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device EsophyX ZR transoral device: TIF
Number of Participants With a Change in PPI Consumption From Baseline to 6 Months	8 Participants

Adverse Events

EsophyX ZR Transoral Device

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EsophyX ZR Transoral Device n=14 participants at risk Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device with Hiatal hernias ≤ 2 and \> 4 cm.
Gastrointestinal disorders Bleeding, hematoma requiring intervention	7.1% 1/14 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Cynthia Harris, Director of Clinical Trials

Daniel and Daniel Consulting, LLC

Phone: 775-392-2975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place