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Procedure

Neurotization for Breast Implant Complications

N/A
Recruiting
Led By Mihye Choi
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women undergoing bilateral nipple-sparing mastectomy (prophylactic or therapeutic) at a single institution
Women receiving implant-based reconstruction (either direct to implant or tissue expander-based implant reconstruction of any size)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 24 post-surgery
Awards & highlights

Study Summary

This trial will investigate if breast neurotization can help restore or improve nipple sensation in breast reconstruction patients. It will be a single-blinded, randomized controlled study.

Who is the study for?
This trial is for women over 18 who are having a bilateral nipple-sparing mastectomy and implant-based breast reconstruction. It's not for those with BMI >30, large breasts needing big implants, severe nerve damage during surgery, diabetes with poor control (HgbA1c >7%), pregnancy, tobacco use, auto-immune diseases, allergy to pig products or prior breast surgeries.Check my eligibility
What is being tested?
The study tests if sensory nerve coaptation (breast neurotization) can restore nipple sensation after breast reconstruction. It's a single-blinded randomized controlled trial where each patient gets the procedure on one breast but not the other to compare results.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include typical surgical complications such as infection risk at the incision site, bleeding, scarring and possibly altered sensation or numbness around the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having both breasts removed without removing the nipples at one hospital.
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I am getting breast reconstruction with an implant.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24 post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SWMT Score in the Nipple (Area 9)
Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9)
Secondary outcome measures
SWMT Score in the Flap Inferior (Area 7)
SWMT Score in the Flap Lateral (Area 6)
SWMT Score in the Flap Medial (Area 8)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Neurotized BreastExperimental Treatment1 Intervention
For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will be neurotized by connecting the lateral intercostal nerve to the nipple with interposing standard nerve grafting techniques. The neurotized breast will serve as the "experimental" breast. The other breast will not receive any breast neurotizing procedure.
Group II: Non-Neurotized BreastActive Control1 Intervention
For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will not receive any breast neurotizing procedure. The non-neurotized breast will serve as the "control" breast.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
817,843 Total Patients Enrolled
Mihye ChoiPrincipal InvestigatorNYU Langone Health

Media Library

Breast Neurotization (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05757778 — N/A
Breast Implant Complications Research Study Groups: Neurotized Breast, Non-Neurotized Breast
Breast Implant Complications Clinical Trial 2023: Breast Neurotization Highlights & Side Effects. Trial Name: NCT05757778 — N/A
Breast Neurotization (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757778 — N/A

Frequently Asked Questions

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

Is there an age cap to qualify for this medical research?

"This clinical trial is enrolling individuals who are of age (18+) and under 99 years old."

Answered by AI

What are the eligibility criteria for participating in this research?

"Prospective enrollees must exhibit symptoms of breast implant complications and be aged between 18 to 99 years. The maximum volume of participants intended for this study is estimated at 88 individuals."

Answered by AI

Are there any open positions available to volunteers for this clinical trial?

"Clinicaltrials.gov discloses that, while posted on March 15th 2021 and last updated February 24th 2021, this trial is no longer looking for patients to enrol. Nonetheless, two other trials are currently admitting participants."

Answered by AI

What are the key goals of this experiment?

"The primary outcome of this clinical trial, evaluated over a Month 12 Post-Surgery time frame, is to measure the Semmes Weinstein Monofilament Test (SWMT) Score in the Nipple (Area 9). Secondary outcomes encompass SWMT Scores from Area 2 and 3 which assess light touch and protective sensation respectively; as well as scores from Area 4 that evaluate deep pressure sensibility."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~56 spots leftby Mar 2026