CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Regenerative Peripheral Nerve Interfaceprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04530526
NCT04530526N/ACompleted
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Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)

University of Michigan Rogel Cancer Center·interventional·Posted Aug 28, 2020·Updated Dec 24, 2025

In Brief

A clinical study evaluating Regenerative Peripheral Nerve Interface for Post-Mastectomy Chronic Pain Syndrome. Completed, enrolled 26 participants across 1 site.

Detailed Summary

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Mastectomy Chronic Pain Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 28, 2020
Enrollment StartJul 12, 2019
Primary CompletionJun 30, 2023
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 5.8 years ago

Interventions

Regenerative Peripheral Nerve Interfaceprocedure

The regenerative peripheral nerve interface (RPNI) has emerged as a novel strategy to treat neuromas in peripheral nerves. The RPNI consists of the residual peripheral nerve end implanted in a skeletal muscle graft, following surgical resection of the injured terminal nerve portion (neuroma). The free muscle graft is separated from its native nerve innervation, leaving open neuromuscular junctions for ingrowth and attachment of nerve fibers from the implanted nerve.