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Neurotization for Breast Implant Complications
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had breast surgery before, such as reduction, augmentation, or lumpectomy.I am scheduled for radiation before or after surgery.My diabetes is not well-controlled (HgbA1c > 7%).My BMI is over 30 or I have larger breasts, which may affect my surgery options.I was not excluded during surgery due to severe damage or removal of lateral nerve targets.I am a man with breast cancer, which is rare.I am having both breasts removed without removing the nipples at one hospital.I am getting breast reconstruction with an implant.I am 18 years old or older.
- Group 1: Neurotized Breast
- Group 2: Non-Neurotized Breast
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
Who else is applying?
What portion of applicants met pre-screening criteria?
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