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Can EndoFLIP Improve Quality of Life Before and After Fundoplication?

NCT06159972 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-12-07

No results posted yet for this study

Summary

Patients with reflux disease (heart burn), or a hiatal hernia, who do not get better with medication, may have surgery to help with their symptoms. Unfortunately, there is no agreed upon way to perform the surgery. The investigators are using a new surgical instrument called the EndoFLIP which allows surgeons to take measurements during the operation. The investigators will compare the measurements obtained during surgery with a quality of life score that we will calculate from a questionnaire.

Conditions

  • GERD
  • Hiatal Hernia

Interventions

DEVICE

EndoFLIP

EndoFLIP is a small balloon catheter that is inserted through the endoscope at the time of endoscopy.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Dr. Wiley Chung

    lead OTHER

Principal Investigators

  • Wiley Chung, MD MHPE · Queen's University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2024-07-05
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159972 on ClinicalTrials.gov