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
Phase-Based Effectiveness
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: Month 24 Post-Surgery
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
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
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
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." - Anonymous Online Contributor
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