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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 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.

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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

Paraesophageal Hernia

Interventions

  • DEVICE Control
  • DEVICE Matristem

Study Locations (1)

Florida

  • Tampa General Hospital - Tampa

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2016-02-02
Est. Completion 2019-01-28

Sponsor

University of South Florida

252 total trials

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What the Registry Record Tells You About NCT03058731

The ClinicalTrials.gov registry entry for NCT03058731 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 6 other Paraesophageal Hernia trials with a reported enrollment target (37% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.