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Scarless surgery? endoscopic mastectomy may keep nipple sensation intact

NCT ID NCT07718425

Symptom relief Sponsor: Massimiliano Bortolini Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study tests a minimally invasive technique called endoscopic nipple-sparing mastectomy for women with breast cancer or high genetic risk. Surgeons remove breast tissue through a small side incision using a camera, then reconstruct the breast immediately with an implant. The goal is to see if this approach reduces scarring and recovery time while preserving nipple sensation and cosmetic outcomes. Thirty women will be followed for up to 5 years to assess safety, sensation recovery, and quality of life.

What this could mean

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

Active substance
endoscopic nipple-sparing mastectomy (a minimally invasive surgical procedure)
What this could lead to
If successful, this approach could offer a less invasive mastectomy option with better cosmetic results and preserved nipple sensation.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply broadly. Surgical risks include infection, necrosis, and implant loss.

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.

Participants

About 30 people

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

Started

Jun 2026

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Thirty consecutive adult women undergoing prophylactic or therapeutic NSM with immediate implant-based reconstruction according to multidisciplinary evaluation.

Ages

18 to 75 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: * Female; age 18-75 years; * indication for prophylactic or therapeutic NSM; * breast volume suitable for endoscopic surgery; * Regnault ptosis ≤ Grade II; * eligibility for immediate implant-based reconstruction; * WHO/ECOG performance status \<3; * written informed consent. Exclusion Criteria: * Inflammatory breast cancer or skin involvement; * previous breast cancer surgery or radiotherapy to the affected breast; * BMI \>35 kg/m²; active smoking; ASA Physical Status \>2; * pregnancy or breastfeeding; * inability to provide informed consent; * participation in incompatible interventional clinical trials.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer Breast reconstruction

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

  • Ospedale degli Infermi ASL BI

    RECRUITING

    Ponderano, BI, 13875, Italy

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