Freedom Inguinal Hernia Repair System Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01984996

Enrollment

100

Registered

2013-11-15

Start date

2013-12-31

Completion date

Unknown

Last updated

2016-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Inguinal Hernia

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.

Interventions

DEVICEFreedom ProFlor Inguinal Hernia Implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * BMI \>35 * Peritoneum cannot be closed

Design outcomes

Primary

Measure	Time frame	Description
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals	1 week, 3, 6, 9, 12, 18, 24, and 36 months.	Measure quality of life for patients undergoing inguinal hernia repair.

Secondary

Measure	Time frame	Description
Evaluate the 14-day pain and medication log	14 days	Patient will record pain score and medications for 14 consecutive days.

Other

Measure	Time frame
Study-related complications/adverse events	3 years

Countries

Austria, Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026