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NCT01863030 · ClinicalTrials.gov registry record

A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery

A clinical trial of Ventral Hernia, sponsored by John Roth.

Completed
Registry status
31
Enrollment target
1
Study location

NCT01863030 is a study of Ventral Hernia that has completed, run by John Roth. The registered enrollment target is 31 participants, below the 141-participant average among 18 other Ventral Hernia trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01863030, a study of Ventral Hernia, has completed, sponsored by John Roth.

COMPLETED
Registry status
31 participants
Enrollment target
1
Study location

Study Summary

The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following: 1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. 2. Perioperative, short-term and long-term procedural and/or device related complications. 3. Abdominal Wall Function and mobility.

Conditions Studied

Interventions

  • DEVICE Phasix mesh implant

Study Locations (1)

Kentucky

  • University of Kentucky Medical Center - Lexington

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2013-05
Est. Completion 2016-11

Sponsor

John Roth

2 total trials

What the Registry Record Tells You About NCT01863030

The ClinicalTrials.gov registry entry for NCT01863030 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 18 other Ventral Hernia trials with a reported enrollment target (78% lower). The listed sponsor is John Roth, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ventral Hernia appearing as the primary indexed condition, and to 1 intervention - of which Phasix mesh implant is the first listed.

NCT01863030 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT01863030 about?

NCT01863030 is a clinical study titled "A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery". The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following: 1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. 2. Perio...

What is the current status of trial NCT01863030?

This trial is currently completed. The enrollment target is 31 participants. The study started on 2013-05. Estimated completion is 2016-11.

What conditions does trial NCT01863030 study?

This clinical trial studies the following conditions: Ventral Hernia.

What interventions are being tested in trial NCT01863030?

The interventions under investigation include: Phasix mesh implant (DEVICE).

Who is sponsoring clinical trial NCT01863030?

This trial is sponsored by John Roth, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01863030 being conducted?

This trial has 1 study location across Kentucky. 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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