Cryoablation for 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.

Inclusion Criteria:

- Status post breast surgical intervention, to include mastectomy, partial mastectomy,
lumpectomy, or reconstruction

- Persistent pain in the distribution of the Intercostobrachial nerve: the residual
breast, surgical bed, ipsilateral medial arm, and/or axilla following tissue healing
(> 1 month postoperative)

- Positive response to local anesthetic nerve block, performed under imaging guidance. A
positive response is defined as a ≥ 3 point change on a standard 11 point visual
analog scale (VAS)

- Ability and willingness to provide informed consent

Exclusion Criteria:

- Active infection

- Underlying cervical segmentation or other cervical spinal anomaly that results in
differential nerve root pressures

- Immunosuppression

- Uncorrectable coagulopathy

- Currently pregnant, nursing or planning to become pregnant.