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NCT04450628 · ClinicalTrials.gov registry record · NA
Esophagogastric Junction Distensibility During Hiatal Hernia Repair
A NA study of Hiatal Hernia and Esophagogastric Junction Distensibility, sponsored by Wake Forest University Health Sciences.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04450628: Active NA study of Hiatal Hernia and Esophagogastric Junction Distensibility, sponsored by Wake Forest University Health Sciences.
NCT04450628 is a NA study of Hiatal Hernia and Esophagogastric Junction Distensibility that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants, below the 888-participant average among 9 other Hiatal Hernia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04450628, a NA study of Hiatal Hernia and Esophagogastric Junction Distensibility, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.
Primary Outcome
Distensibility index of esophagogastric junction will be measured 8cm EndoFLIP balloon at baseline and after hiatal hernia repair.
Conditions Studied
Interventions
- DEVICE EndoFLIP
Study Locations (1)
North Carolina
- Atrium Health - Carolinas Medical Center - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2026-09 |
| Phase | NA |
What the registry record for NCT04450628 still lists
NCT04450628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 888-participant average among 9 other Hiatal Hernia trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Hiatal Hernia appearing as the primary indexed condition, and to 1 intervention - of which EndoFLIP is the first listed.
NCT04450628 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04450628 about?
NCT04450628 is a clinical study titled "Esophagogastric Junction Distensibility During Hiatal Hernia Repair". The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and...
What is the current status of trial NCT04450628?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2020-09-28. Estimated completion is 2026-09.
What conditions does trial NCT04450628 study?
This clinical trial studies the following conditions: Hiatal Hernia, Esophagogastric Junction Distensibility.
What interventions are being tested in trial NCT04450628?
The interventions under investigation include: EndoFLIP (DEVICE).
Who is sponsoring clinical trial NCT04450628?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04450628 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hiatal Hernia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04450628's enrollment target sits among peer trials
25 10th of 9 the lowest of 9 other Hiatal Hernia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hiatal Hernia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
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-
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-
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-
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
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-
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
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-
Miromatrix Biological Mesh for Hiatal Hernia Repair
COMPLETED · NA
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