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Cryoablation for Post Mastectomy Pain Syndrome

CompletedNot applicableNCT03293940
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome
Conditions
  • Post-Mastectomy Chronic Pain Syndrome (Disorder)
Interventions
  • Procedure: Cryoablation
  • Procedure: Therapeutic Peripheral Nerve Block (tPNB) Injection
Sponsor
Emory University
Start date
2018-01-10
Primary completion
2021-05-19
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03293940