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Reconnecting nerves during breast reconstruction may bring back sensation

NCT ID NCT07767838

Symptom relief Sponsor: Hospital Angeles del Pedregal 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study tests whether a surgical technique called nipple neurotization, performed during a two-stage breast reconstruction, can help restore feeling in the nipple after a mastectomy. Women who had a nipple-sparing mastectomy and are undergoing expander-to-implant exchange may receive this nerve reconnection procedure. Researchers will measure sensory recovery using standard tests to see if the approach improves sensation in the nipple area.

What this could mean

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

Active substance
Nipple neurotization (a surgical procedure to reconnect nerves during breast reconstruction)
What this could lead to
If it works, this could help women regain sensation in the nipple after mastectomy and breast reconstruction, improving quality of life.
What could go wrong
This is a small, early study, and nerve recovery is uncertain. The procedure may not restore full sensation, and results may not apply to all patients.

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

18 people

The number who actually took part.

Started

Jan 2021

Finished

Dec 2025

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 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 * Adult female patients (≥18 years of age). * Patients who underwent nipple-sparing mastectomy (NSM) with immediate tissue-expander placement. * Patients undergoing nipple neurotization at the time of expander-to-implant exchange. * Patients with a clinically viable nipple-areola complex (NAC) at the time of neurotization. * Patients who underwent standardized sensory assessment of the breast/NAC preoperatively and at least one postoperative time point. * Patients who provided informed consent for participation and postoperative sensory assessment. Exclusion criteria * Patients younger than 18 years of age. * Male patients. * Patients who underwent a mastectomy other than nipple-sparing mastectomy. * Patients who underwent nipple neurotization at a time other than the expander-to-implant exchange. * Patients unable to undergo standardized sensory testing or unable to reliably report sensory perception. * Patients without adequate postoperative follow-up to perform the required sensory assessments. * Patients who declined participation or withdrew consent.

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As listed by the trial registrant

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

Breast reconstruction

Contacts and locations

Locations

  • Hospital Angeles Pedregal

    Mexico City, Mexico City, 10700, Mexico

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