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Nerve graft aims to bring back sensation after mastectomy

NCT ID NCT05757778

Symptom relief Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a nerve reconstruction procedure can restore nipple sensation in women undergoing implant-based breast reconstruction after mastectomy. Six women having bilateral reconstruction will receive the nerve graft on one breast only, acting as their own control. The main goal is to measure sensation using a monofilament test.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sensory nerve coaptation (nerve reconstruction using a nerve graft)
What this could lead to
If it works, this could help restore nipple sensation after mastectomy and implant-based reconstruction, improving quality of life.
What could go wrong
This is a very small, early study with only 6 participants, so results may not apply to everyone. The procedure is surgical and carries risks like infection or nerve damage.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Apr 2027

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

18 to 99 years

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: * Women undergoing bilateral nipple-sparing mastectomy (prophylactic or therapeutic) at a single institution * Women receiving implant-based reconstruction (either direct to implant or tissue expander-based implant reconstruction of any size) * Age 18 or older Exclusion Criteria: * Women with history of prior breast surgery given concern for potentially damaged nerves by prior intervention that could impact the procedure and results. Procedures include but are not limited to: prior breast reduction, prior breast augmentation, prior lumpectomy * Pre-operative radiation or anticipated post-operative radiation * Body Mass Index (BMI) \> 30 kg/m2 or patients with macromastia (larger breasts) as these patients frequently require larger implants that will not accommodate the longest nerve graft available (70 mm) * Current tobacco or nicotine use * History of diabetes mellites with a HgbA1c \> 7% due to lower rates of wound healing * History of auto-immune disease * History of allergy, sensitivity, or intolerance to porcine-derived materials * Intraoperatively, patients may have to be excluded if during the mastectomy the lateral nerve targets were severely damaged or removed as part of the mastectomy. While these patients will be excluded from the formal analysis, the investigators will continue to follow them as a subgroup for analysis and comparison. * Men as they infrequently receive bilateral mastectomies due to breast cancer. Male breast cancer is \<1% of all breast malignancies. * Pregnancy as determined by urine pregnancy test on day of surgery

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast implant complications

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

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