Donor nerve grafts put to the test for restoring feeling after mastectomy
NCT ID NCT07819357
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
This trial tests whether adding a donor nerve graft during implant-based breast reconstruction helps women regain breast and nipple sensation after nipple-sparing mastectomy. Each participant has one breast randomly chosen to receive the graft, while the other breast serves as a comparison. Researchers measure sensation with a light-touch test and questionnaires before surgery and at about 6, 12, and 24 months afterward. The goal is to see if the grafted breast recovers more feeling than the non-grafted breast.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a processed donor nerve graft (Avance Nerve Scaffold) used to rebuild the sensory nerve pathway during breast reconstruction
- What this could lead to
- If it works, donor nerve grafts could become a routine part of breast reconstruction, helping women regain feeling in their breasts and nipples after mastectomy.
- What could go wrong
- The trial is small, with 45 participants, and nerve regrowth is slow and unpredictable. Sensation may not return, or the graft may not outperform standard reconstruction without it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female subjects greater or equal to 22 years of age. * Subject is considered a candidate for nipple sparing mastectomy by the breast and plastic surgeon * First-time breast reconstruction post-mastectomy for target breasts. * Subject is planning to undergo bilateral nipple-sparing mastectomy with immediate, implant-based, subpectoral or prepectoral breast reconstruction. * Mastectomy performed to address ductal carcinoma-in-situ (DCIS) or for cancer prophylaxis. * An informed consent form is signed by subject * Subject is capable of following protocol procedures and complying with follow-up visit requirements. Exclusion Criteria: * Subject has undergone prior radiation therapy to the reconstruction site or chest wall. * Subject has a BMI \> 35. * Subject has a known diagnosis of diabetes with a HbA1c \> 7.0mmol/L within 30 days of the mastectomy * Subject is a tobacco/nicotine user within 30 days prior to Index Surgery. * Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction. * Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up. * Subject is currently participating or planning to participate in another investigational drug, biologic, or medical device study that may interfere with compliance of this study requirements or may confound this study data/outcomes. * Subject is pregnant or lactating at the time of the mastectomy. * If the patient has a diagnosis of DCIS, there no radiographic evidence of DCIS within 1 cm of the skin or nipple or foci suspicious for microinvasion. * Patients with a diagnosis of grade III DCIS.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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501 Skokie Blvd Ste 250
Northbrook, Illinois, 60062, United States
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Evanston Hospital
Evanston, Illinois, 60201, United States
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Highland Park Hospital
Highland Park, Illinois, 60035, United States
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