Status:
COMPLETED
Cryoablation for Post Mastectomy Pain Syndrome
Lead Sponsor:
Emory University
Conditions:
Post-Mastectomy Chronic Pain Syndrome (Disorder)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 cryoablati...
Detailed Description
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 cryoablati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03293940
Start Date
January 10 2018
End Date
May 19 2021
Last Update
October 8 2021
Active Locations (4)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Emory St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
4
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097