Freedom Inguinal Hernia Repair System Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Inguinal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Freedom ProFlor Inguinal Hernia Implant

Group Type EXPERIMENTAL

Freedom ProFlor Inguinal Hernia Implant

Intervention Type DEVICE

Interventions

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Freedom ProFlor Inguinal Hernia Implant

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No