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Procedure

Nerve Grafting for Sensation Restoration After Mastectomy in Breast Cancer

Q: Has the FDA authorized any medical uses of ARM II (neurotization)?

<p>With some evidence of safety but no data confirming efficacy, our team at Power rated the ARM II (neurotization) procedure a 2 on its 1 to 3 scale.</p>

Q: Is the enrollment period still open for this experiment?

<p>As per information on clinicaltrials.gov, this healthcare trial is not currently recruiting patients. Initially posted on January 1st 2024 and last updated November 30th 2023, the study's recruitment period has ended; however 2380 other studies are actively seeking participants at present.</p>

Phase 2

Recruiting

Led By James W. Jakub, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Female patients age >= 18 undergoing NSM

Ptosis grade =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests if patients undergoing mastectomy to prevent breast cancer can have nerve grafts to restore sensation in the nipple. It also compares how this affects satisfaction and quality of life.

Who is the study for?

This trial is for female breast cancer patients aged 18 or older who are undergoing nipple sparing mastectomy (NSM) with specific criteria: ECOG status of 0-2, A-C cup size, BMI ≤34, ptosis grade ≤2, clinical stage 0-T2N0, and implant volume ≤400cc. Exclusions include prior breast cancer treatments or surgeries on the affected side and active nicotine use.Check my eligibility

What is being tested?

The study tests if adding a neurotization procedure to NSM can restore sensation in the nipple area. It compares patient satisfaction between those who have standard NSM and those who receive additional nerve grafting aimed at improving quality of life and sexual functionality of the breast.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include typical surgical risks such as infection, bleeding, scarring; specific to neurotization could be altered sensation or numbness around the operated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 18 planning to have nipple-sparing mastectomy.

Select...

My eyelid droop is mild or moderate.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My cancer is in an early stage and has not spread to lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization

Secondary outcome measures

Chest physical well-being

Incidence of adverse events (AEs)

Mastectomy skin flap necrosis

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM II (neurotization)Experimental Treatment3 Interventions

Patients undergo neurotization during standard of care NSM on study.

Group II: ARM I (control)Active Control2 Interventions

Patients undergo standard of care NSM on study.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,997 Total Patients Enrolled

83 Trials studying Breast Cancer

13,810 Patients Enrolled for Breast Cancer

James W. Jakub, M.D.Principal InvestigatorMayo Clinic

Frequently Asked Questions

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

Has the FDA authorized any medical uses of ARM II (neurotization)?

"With some evidence of safety but no data confirming efficacy, our team at Power rated the ARM II (neurotization) procedure a 2 on its 1 to 3 scale."

Answered by AI

Is the enrollment period still open for this experiment?

"As per information on clinicaltrials.gov, this healthcare trial is not currently recruiting patients. Initially posted on January 1st 2024 and last updated November 30th 2023, the study's recruitment period has ended; however 2380 other studies are actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

2023. "Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153836.