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A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

NCT02240550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-01-18

No results posted yet for this study

Summary

This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.

Conditions

  • Inguinal Hernia

Interventions

DEVICE

ProFlor Hernia Repair System

The 3-D hernia mesh will be used in the repair of your inguinal hernia.

DEVICE

Lichtenstein hernia repair

The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.

Sponsors & Collaborators

  • Insightra Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • John Murphy, MD · Healing Hands Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02240550 on ClinicalTrials.gov