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Donor nerve grafts put to the test for restoring feeling after mastectomy

NCT ID NCT07819357

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

22 years and older

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 501 Skokie Blvd Ste 250

    Northbrook, Illinois, 60062, United States

  • Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Highland Park Hospital

    Highland Park, Illinois, 60035, United States

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