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NCT06193551 · ClinicalTrials.gov registry record · NA
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
A NA study of Paraesophageal Hernia and Large Hiatal Hernia, sponsored by Foregut Research Foundation.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06193551: Recruiting NA study of Paraesophageal Hernia and Large Hiatal Hernia, sponsored by Foregut Research Foundation.
NCT06193551 is a NA study of Paraesophageal Hernia and Large Hiatal Hernia that is actively recruiting participants, run by Foregut Research Foundation. The registered enrollment target is 100 participants, roughly in line with the 99-participant average among 6 other Paraesophageal Hernia 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
NCT06193551, a NA study of Paraesophageal Hernia and Large Hiatal Hernia, is actively recruiting participants, sponsored by Foregut Research Foundation.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.
Primary Outcome
Assess recurrence rates by objective measures when Ovitex LPR permanent polypropylene polymer reinforcement (Ovitex LPR) is placed during robotic-assisted repair of paraesophageal and large (\> 5cm) hiatal hernias (henceforth PEH) using recurrence rate measurements defined as \> 2cm axial hernia by Barium Swallow or endoscopy, if available
Conditions Studied
Interventions
- DEVICE Ovitex LPR
Study Locations (1)
Colorado
- Institute of Esophageal and Reflux Surgery - Lone Tree
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-02-19 |
| Est. Completion | 2030-06 |
| Phase | NA |
What NCT06193551 shows while recruiting
NCT06193551 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 99-participant average among 6 other Paraesophageal Hernia trials with a reported enrollment target.
The record links to 2 conditions, with Paraesophageal Hernia appearing as the primary indexed condition, and to 1 intervention - of which Ovitex LPR is the first listed.
NCT06193551 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06193551 about?
NCT06193551 is a clinical study titled "Ovitex in Paraesophageal and Large Hiatal Hernia Repair". The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.
What is the current status of trial NCT06193551?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-02-19. Estimated completion is 2030-06.
What conditions does trial NCT06193551 study?
This clinical trial studies the following conditions: Paraesophageal Hernia, Large Hiatal Hernia.
What interventions are being tested in trial NCT06193551?
The interventions under investigation include: Ovitex LPR (DEVICE).
Who is sponsoring clinical trial NCT06193551?
This trial is sponsored by Foregut Research Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06193551 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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