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EndoFLIP for Hiatal Hernia and Acid Reflux

N/A
Recruiting
Led By Wiley Chung, MD MHPE
Research Sponsored by Dr. Wiley Chung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Those with a previous history of hiatal hernia repair, fundoplication, esophagectomy, or gastrectomy
Inability to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 (four) months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at a new surgical instrument to help treat reflux & hiatal hernia patients. Measurements taken during surgery are compared to quality of life scores to assess effectiveness.

Who is the study for?
This trial is for adults being evaluated for GERD (heartburn) or symptomatic hiatal hernia who are planning to have fundoplication surgery. It's not open to those who've had previous surgeries like hiatal hernia repair, fundoplication, esophagectomy, or gastrectomy, or can't consent.
What is being tested?
The study tests the EndoFLIP instrument during fundoplication surgery. Surgeons will use it to take measurements that could influence surgical technique and outcomes. The goal is to see if these measurements correlate with improved quality of life post-surgery.
What are the potential side effects?
Since EndoFLIP is a tool used during surgery rather than a drug, side effects may be related to the procedure itself such as discomfort at the measurement site or potential complications from standard surgical risks.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery on my esophagus or stomach.
Select...
I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 (four) months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 (four) months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intraoperative EndoFLIP and postoperative quality of life using the "GERD health related quality of life" score
Secondary study objectives
Intraop EndoFLIP and preop + postop manometry and pH monitoring

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EndoFLIPExperimental Treatment1 Intervention
Intraop EndoFLIP measurements
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EndoFLIP
2017
N/A
~50

Find a Location

Who is running the clinical trial?

Dr. Wiley ChungLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,038 Total Patients Enrolled
Wiley Chung, MD MHPEPrincipal InvestigatorQueen's University
~18 spots leftby Nov 2025
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