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New surgery aims to restore feeling in reconstructed breasts

NCT ID NCT07308275

Symptom relief Sponsor: Fakultas Kedokteran Universitas Indonesia 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether reconnecting nerves during breast reconstruction can improve sensation and quality of life. Twenty-eight women who had a mastectomy will be randomly assigned to receive either standard reconstruction or reconstruction with a nerve graft. Researchers will measure sensation, patient-reported outcomes, and biological markers over six months.

What this could mean

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

Active substance
nerve graft procedure
What this could lead to
If it works, this could offer a way to restore feeling in reconstructed breasts after mastectomy, improving quality of life.
What could go wrong
This is a small, early-stage trial with only 28 participants, so results may not apply widely. The procedure is surgical and carries typical 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

About 28 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

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 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 patients aged ≥18 years. * Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy. * Patients undergoing breast reconstruction. * Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and/or chemotherapy or receiving no adjuvant therapy). * Willing to comply with all scheduled examinations and tissue sampling procedures. * Able and willing to provide written informed consent. Exclusion Criteria: * History of peripheral neuropathy (e.g., diabetes mellitus with neuropathic complications). * Bilateral mastectomy. * Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment. * Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization). * Refusal or inability to attend follow-up evaluations.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Breast reconstruction after mastectomy Mastectomy and breast reconstruction Neurotization Peripheral nerve regeneration Quality of life (QOL) Sensory function

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • dr. Ciptomangunkusumo National Hospital - Faculty of Medicine Universitas Indonesia

    Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

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