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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 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.

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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

Interventions

  • DEVICE OviTex Mesh
  • OTHER Pledgeted sutures

Study Locations (1)

Ohio

  • Cleveland Clinic Center for Abdominal Core Health - Cleveland

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2023-09-11
Est. Completion 2028-12
Phase NA

Sponsor

David Krpata

2 total trials

What the Registry Record Tells You About NCT05974722

The ClinicalTrials.gov registry entry for NCT05974722 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 157-participant average among 15 other GERD trials with a reported enrollment target. The listed sponsor is David Krpata, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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