Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface
CompletedNot applicableNCT04530526
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)
Post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life. The investigators on this study will evaluate the regenerative peripheral nerve interface (RPNI), a novel surgical approach to neuroma treatment, to improve patient-reported post-mastectomy pain and definitively treat intercostal neuromas after mastectomy.
Study details
- Official title
- Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)
- Conditions
- Post-Mastectomy Chronic Pain Syndrome
- Interventions
- Procedure: Regenerative Peripheral Nerve Interface
- Sponsor
- University of Michigan Rogel Cancer Center
- Collaborators
- National Cancer Institute (NCI)
- Start date
- 2019-07-12
- Primary completion
- 2023-06-30
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Reporting post-mastectomy pain at least six months removed from mastectomy or partial mastectomy (lumpectomy). * Willing to comply with all study procedures and be available for the duration of the study * Fluent in English * Women of reproductive potential must use highly effective contraception (specify methods of contraception acceptable for the study, e.g., licensed hormonal methods) and/or willingness to undergo a pregnancy test. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Previous surgical management for chronic post-mastectomy pain * Signs/symptoms which are not suggestive of neuropathic pain based on physical exam at time of consultation. * Pregnancy or lactation * Men will not be enrolled in this study due to the low prevalence of male mastectomy. * Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04530526