Cryoablation for Post Mastectomy Pain Syndrome

Completed · Not applicable

Conditions studied: Post-Mastectomy Chronic Pain Syndrome (Disorder)

In brief

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.

Key facts

Study ID

NCT03293940

Run by

Emory University

People needed

35

Starts

2018-01-10

Expected to finish

2021-05-19

Last updated by the study team

2021-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Emory St. Joseph's Hospital — Atlanta, Georgia, United States
• Emory Johns Creek Hospital — Johns Creek, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.