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Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair

NCT01877122 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-06-25

No results posted yet for this study

Summary

Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.

Conditions

  • Hernia, Inguinal

Interventions

DEVICE

Proflex® Mesh Mesh implantation

Implantation of mesh in the incision of inguinal area

DEVICE

Marlex® Mesh Implant

Sponsors & Collaborators

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Taeil Son, M.D., Ph.D. · Eulji Medical Center

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • South Korea

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 NCT01877122 on ClinicalTrials.gov