438 Studies Now Enrolling
Post-market, prospective evaluation of PHOTO-oxidized decellularized bovine pericardium used as a patch in Vascular repair and reconstruction surgery: PHOTO-V
Study of the Efficacy and Durability of the PhotoFix Patch in Vascular Repair and Reconstruction
| Sponsor: | CryoLife, Inc |
| Enrolling: | Male and Female Patients |
| Study Length: | 6 Months |
| Clinic Visits: | 3 |
| IRB Number: | AAAS0091 |
| U.S. Govt. ID: | NCT03669042 |
| Contact: | Claudia Musat, Study Manager: 212-342-4102 / cm2065@cumc.columbia.edu |
Additional Study Information:
All vascular repair and reconstruction surgery requires patching material. PhotoFix, made of cow heart membrane, is one of the FDA-approved patches on the market for use in vascular repair and reconstruction surgery. Other vascular patches on the market are also available and used by other surgeons for procedures like the one you need. This trial will study how well the PhotoFix patch works as a part of your surgical treatment. If you decide to be a part of this study, the results of your surgery will be compared to the results of about 100 other study volunteers who have undergone procedures like yours at other hospitals.
This study is closed
Do You Qualify?
| Are you undergoing a vascular surgery that requires the use of the PhotoFix Decellularized Bovine Pericardium Patch? | Yes | No |
| Is your vascular operation going to take place within 60 days from now? | Yes | No |
| Are you 18 years of age or older? | Yes | No |
| Do you have a medical history of cancer or severe immunodeficiency disease? | Yes | No |
| Have you had medical procedures before in which the doctor had to cut into your arteries and/or veins? | Yes | No |