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NCT05974722 · ClinicalTrials.gov registry record · NA
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
A NA study of GERD and Paraesophageal Hernia, sponsored by David Krpata.
- Recruiting
- Registry status
- NA
- Development phase
- 164
- Enrollment target
- 1
- Study location
NCT05974722: Recruiting NA study of GERD and Paraesophageal Hernia, sponsored by David Krpata.
NCT05974722 is a NA study of GERD and Paraesophageal Hernia that is actively recruiting participants, run by David Krpata. The registered enrollment target is 164 participants, roughly in line with the 157-participant average among 15 other GERD trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05974722, a NA study of GERD and Paraesophageal Hernia, is actively recruiting participants, sponsored by David Krpata.
- RECRUITING
- Registry status
- NA
- Development phase
- 164 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: * Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair. * Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms
Primary Outcome
The primary endpoint of this study is the binary 2-year rate of radiographic recurrence of the paraesophageal hernia, defined gastroesophageal junction at least 2 cm above the hiatus on upper gastrointestinal studies, CT, or MRI.
Conditions Studied
Interventions
- DEVICE OviTex Mesh
- OTHER Pledgeted sutures
Study Locations (1)
Ohio
- Cleveland Clinic Center for Abdominal Core Health - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2023-09-11 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT05974722 shows while recruiting
NCT05974722 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 157-participant average among 15 other GERD trials with a reported enrollment target.
The record links to 2 conditions, with GERD appearing as the primary indexed condition, and to 2 interventions - of which OviTex Mesh is the first listed.
NCT05974722 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05974722 about?
NCT05974722 is a clinical study titled "Mesh Vs Pledgets for Repair of Paraesophageal Hernia". The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: * Dete...
What is the current status of trial NCT05974722?
This trial is currently recruiting. It is a NA study. The enrollment target is 164 participants. The study started on 2023-09-11. Estimated completion is 2028-12.
What conditions does trial NCT05974722 study?
This clinical trial studies the following conditions: GERD, Paraesophageal Hernia.
What interventions are being tested in trial NCT05974722?
The interventions under investigation include: OviTex Mesh (DEVICE), Pledgeted sutures (OTHER).
Who is sponsoring clinical trial NCT05974722?
This trial is sponsored by David Krpata, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05974722 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for GERD
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 NCT05974722's enrollment target sits among peer trials
164 5th of 15 higher than 11 of 15 other GERD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other GERD 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
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