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EndoFLIP for Hiatal Hernia

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 (four) months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 (four) months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intraoperative EndoFLIP and postoperative quality of life using the "GERD health related quality of life" score

Secondary outcome measures

Intraop EndoFLIP and preop + postop manometry and pH monitoring

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dr. Wiley ChungLead Sponsor

1 Previous Clinical Trials

70 Total Patients Enrolled

MedtronicIndustry Sponsor

607 Previous Clinical Trials

828,625 Total Patients Enrolled

Wiley Chung, MD MHPEPrincipal InvestigatorQueen's University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in the experiment?

"Affirmative, the clinicaltrials.gov database demonstrates that this experiment is still recruiting participants. The trial was first posted on May 1st 2023 and has been edited as recently as December 5th of the same year. It needs approximately 50 patients to be enrolled from a single site."

Answered by AI

Are there opportunities to join this medical experiment at the present time?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial is actively recruiting, having been published on 5th of January 2023 and last revised on the 12th of May in the same year. The research requires 50 patients to be recruited from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Can EndoFLIP Improve Quality of Life Before and After Fundoplication?

Dr. Wiley Chung 2023. "Can EndoFLIP Improve Quality of Life Before and After Fundoplication?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06159972.