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Regenerative Peripheral Nerve Interface (RPNI) for Post Mastectomy Pain Syndrome (RPNI Trial)

N/A

Waitlist Available

Led By David L Brown, M.D.

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 - 24 months

Awards & highlights

RPNI Trial Summary

This trial will evaluate a new surgical approach to treating post-mastectomy pain caused by nerve damage. The hope is that this will improve patients' quality of life.

Eligible Conditions

Post Mastectomy Pain Syndrome

RPNI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 - 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 - 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 - 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in depression/anxiety scores

Change in opioid consumption

Change in pain level

+2 more

RPNI Trial Design

1Treatment groups

Experimental Treatment

Group I: Regenerative Peripheral Nerve Interface (RPNI)Experimental Treatment1 Intervention

Using evaluative ultrasound measurements and a standard panel of patient-reported outcome measures (PROMs) to measure pain experience, anxiety and depression, patients will be evaluated at baseline (T1=0months), pre-operatively following 3 months of standard neuropathic pain management therapy (T2=3months) and at three months (T3=6months) and nine months (T4=12months) post RPNI surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regenerative Peripheral Nerve Interface

2019

N/A

~30

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Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

293 Previous Clinical Trials

24,072 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,642 Total Patients Enrolled

David L Brown, M.D.Principal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities for participants to join this clinical trial?

"Data hosted on clinicaltrials.gov shows that this medical trial is presently searching for patients to participate. It was initially announced on the 12th of July 2019 and most recently modified on 28 November 2022."

Answered by AI

What is the projected participant count of this research endeavor?

"Affirmative. Clinicaltrials.gov's information indicates that this clinical trial, which began recruiting on July 12th 2019 is actively looking for participants. 25 patients need to be selected from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface

2019. "Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04530526.