Study Stopped
Company was dissolved.
Freedom Inguinal Hernia Repair System Study
1 other identifier
interventional
100
3 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedJune 9, 2016
January 1, 2016
4 years
November 4, 2013
June 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
Measure quality of life for patients undergoing inguinal hernia repair.
1 week, 3, 6, 9, 12, 18, 24, and 36 months.
Secondary Outcomes (1)
Evaluate the 14-day pain and medication log
14 days
Other Outcomes (1)
Study-related complications/adverse events
3 years
Study Arms (1)
Freedom ProFlor Inguinal Hernia Implant
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Scheduled to undergo routine inguinal hernia repair
- Competent to give consent
- Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
- Defect size at operation is between 5mm and 35mm
- Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
- Primary hernia at the operative site
- Male or female
- Life expectancy of at least 12 months
- At least 18 years of age
You may not qualify if:
- Signs of obvious local or systemic infection
- Any previous surgery on the hernia operative site
- Hernia is not in the inguinal area
- Hernia is not identified as indirect or direct
- Femoral hernias
- Known collagen disorder
- Presenting with unstable angina or NYHA class of IV
- Known Pregnancy
- Active drug user
- Recurrence of a repair by any method
- Patients with giant inguinoscrotal hernia or abdominal wall defect \>35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
- Immunosuppression, prednisone\>15 mg/day, active chemotherapy
- End stage renal disease
- Abdominal ascites
- Skin infection in area of surgical field
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Metabolic Clinic and Research Center
Los Angeles, California, 90033, United States
Witham Health Services
Lebanon, Indiana, 46052, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808, United States
New Hannover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Herz Jesu Krankenhaus GmbH
Vienna, A-1030, Austria
Istituto Clinico Sant'Ambrogio
Milan, 20149, Italy
Azienda Policlinico Umberto I
Roma, 00161, Italy
Policlinico Tor Vergata
Roma, 00161, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Karl LeBlanc, M.D., M.B.A., F.A.C.S.
Our Lady of the Lake Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2013
First Posted
November 15, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2017
Last Updated
June 9, 2016
Record last verified: 2016-01