Surgeon unblinded for Esophagogastric Junction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Esophagogastric Junction+3 More
Surgeon unblinded - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether surgery to repair a hiatal hernia and to strengthen the valve between the stomach and esophagus improves GERD symptoms and makes it easier to swallow.

Eligible Conditions
  • Esophagogastric Junction
  • Hiatus Hernia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 6 months

6 months
Change in distensibility index
Post-op GERD symptoms
Post-op dysphagia symptoms

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Surgeon blinded
1 of 2
Surgeon unblinded
1 of 2

Active Control

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Surgeon unblinded · No Placebo Group · N/A

Surgeon unblindedExperimental Group · 2 Interventions: Surgeon unblinded, EndoFLIP 1.0 System EF-100 · Intervention Types: Procedure, Device
Surgeon blindedNoIntervention Group · 1 Intervention: Surgeon blinded · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,114 Previous Clinical Trials
1,129,516 Total Patients Enrolled
Atrium HealthLead Sponsor
121 Previous Clinical Trials
35,406 Total Patients Enrolled
MedtronicIndustry Sponsor
571 Previous Clinical Trials
732,598 Total Patients Enrolled
Paul D Colavita, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication.
You are an adult patient.\n
You have had an elective repair of a cleft lip or palate.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: November 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Atrium Health - Carolinas Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%