OHSU

IRB #

IRB00010062

Title

A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair

Principal Investigator

Robert Martindale

Study Purpose

To collect long-term data on the use of an approved mesh used to treat hernias (Phasix Mesh).

Medical Condition(s)

Those diagnosed with primary ventral, incisional hernia, or first time recurrent ventral or incisional hernia (with additional health problems/issues).

Eligibility Criteria

Male or Female, 18 an older, with diagnosed hernia (as discussed above) in need of repair. Must have another pre-existing conditions such as; smoking, diabetes, heart disease, COPD, obesity, older than 75.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

The study is about 25 months long - beginning 30 days prior to the surgery and continuing for about 2 years after the surgery.

Minors Included

No

Contact

Charlie Borzy
503-494-4949

Sponsor

Davol Inc.
(Subsidary of C.R. Bard Inc)

Recruitment End

09/30/2014

Compensation Provided

Yes

Compensation

Subjects will receive $50 for each visit they complete after they have been discharged from OHSU. If a subject completes the entire study they could receive up to $300.


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