Post-Mastectomy Chronic Pain Syndrome (Disorder) Clinical Trial
Official title:
Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome
This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.
This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment of post mastectomy pain syndrome. Participants will be randomized to receive cryoablation or a therapeutic peripheral nerve block injection (tPNB). All participants will be evaluated at baseline and after treatment at 10 days, 90 days, and 180 days via clinical visits. The option to undergo cryoablation or tPNB will be offered to all participants at the end of the 90 day post-procedure assessment. Each subject that elects the crossover intervention will be assessed over the same time period and in an identical fashion to the initial intervention, including a final long term follow up (LTFU) assessment at 180 days post-cryoablation. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03081286 -
Treatment of Postmastectomy Pain Syndrome With Fat Grafting
|
N/A |