MedTrace Logo

Freedom Inguinal Hernia Repair System Study

NCT01984996 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-06-09

No results posted yet for this study

Summary

The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.

The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.

Conditions

  • Primary Inguinal Hernia

Interventions

DEVICE

Freedom ProFlor Inguinal Hernia Implant

Sponsors & Collaborators

  • Insightra Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Karl LeBlanc, M.D., M.B.A., F.A.C.S. · Our Lady of the Lake Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-12-31

Countries

  • United States
  • Austria
  • Italy

Study Locations

More Related Trials

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 NCT01984996 on ClinicalTrials.gov