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NCT03058731 · ClinicalTrials.gov registry record
ACELL Mesh for Paraesophageal Hernia Repair
A clinical trial of Paraesophageal Hernia, sponsored by University of South Florida.
- Completed
- Registry status
- 65
- Enrollment target
- 1
- Study location
NCT03058731: Completed study of Paraesophageal Hernia, sponsored by University of South Florida.
NCT03058731 is a study of Paraesophageal Hernia that has completed, run by University of South Florida. The registered enrollment target is 65 participants, below the 104-participant average among 6 other Paraesophageal Hernia trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03058731, a study of Paraesophageal Hernia, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.
Conditions Studied
Interventions
- DEVICE Control
- DEVICE Matristem
Study Locations (1)
Florida
- Tampa General Hospital - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2016-02-02 |
| Est. Completion | 2019-01-28 |
What the finished NCT03058731 record still lists
NCT03058731 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 104-participant average among 6 other Paraesophageal Hernia trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Paraesophageal Hernia appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT03058731 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03058731 about?
NCT03058731 is a clinical study titled "ACELL Mesh for Paraesophageal Hernia Repair". This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reasses...
What is the current status of trial NCT03058731?
This trial is currently completed. The enrollment target is 65 participants. The study started on 2016-02-02. Estimated completion is 2019-01-28.
What conditions does trial NCT03058731 study?
This clinical trial studies the following conditions: Paraesophageal Hernia.
What interventions are being tested in trial NCT03058731?
The interventions under investigation include: Control (DEVICE), Matristem (DEVICE).
Who is sponsoring clinical trial NCT03058731?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03058731 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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