Recruiting

EndoFLIP

Sponsor:

Dr. Wiley Chung

Code:

NCT06159972

Conditions

GERD

Hiatal Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EndoFLIP

Study Details

Brief 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

Study ID

NCT06159972

Start date

Jan 5, 2023

Status verified date

Dec, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jul 5, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients undergoing workup for gastroesophageal reflux disease (GERD) and/or symptomatic hiatal hernia who undergo fundoplication AND who undergo fundoplication

Exclusion Criteria:

  • Those with a previous history of hiatal hernia repair, fundoplication, esophagectomy, or gastrectomy
  • Inability to provide consent

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EndoFLIP

Intraop EndoFLIP measurements

Interventions

EndoFLIP

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

Primary outcome measure

  • Intraoperative EndoFLIP and postoperative quality of life using the "GERD health related quality of life" score [ Time Frame: 4 (four) months ]

Central Contacts and Locations

Central contacts

Nader M Hanna, MBBS, MSc

(613) 549-6666nader.hanna@queensu.ca

Locations

KHSC

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Wiley Chung, MD, MHPE

(613) 549-6666wiley.chung@kingstonhsc.ca

More Information

Sponsor

Dr. Wiley Chung

Last update posted

Dec 7, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Wiley Chung on 2023-12-07.