Neurotized Breast for Breast Implant Complications

NYU Langone Health, New York, NY
Breast Implant ComplicationsSensory Nerve Coaptation - Procedure
18 - 99

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.

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Month 24 Post-Surgery

Month 12 Post-Surgery
Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9)
Month 24 Post-Surgery
SWMT Score in the Flap Inferior (Area 7)
SWMT Score in the Flap Lateral (Area 6)
SWMT Score in the Flap Medial (Area 8)
SWMT Score in the Flap Superior (Area 5)
SWMT Score in the Mastectomy Inferior (Area 3)
SWMT Score in the Mastectomy Lateral (Area 2)
SWMT Score in the Mastectomy Medial (Area 4)
SWMT Score in the Mastectomy Superior (Area 1)
SWMT Score in the Nipple (Area 9)

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Non-Neurotized Breast
1 of 2
Neurotized Breast
1 of 2

Active Control

Experimental Treatment

88 Total Participants · 2 Treatment Groups

Primary Treatment: Neurotized Breast · No Placebo Group · N/A

Neurotized Breast
Experimental Group · 1 Intervention: Sensory Nerve Coaptation · Intervention Types: Procedure
Non-Neurotized BreastNoIntervention Group · 1 Intervention: Non-Neurotized Breast · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 24 post-surgery

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,306 Previous Clinical Trials
761,667 Total Patients Enrolled
Mihye ChoiPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 18 - 99 · Female Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

" 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.