Keyhole breast surgery: a gentler option for cancer patients?
NCT ID NCT07579117
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study is testing a new, less invasive breast surgery called endoscopic video-assisted nipple-sparing mastectomy (E-NSM) for women with early-stage breast cancer or those at high risk. The goal is to see if this technique can reduce surgical trauma and improve cosmetic results while keeping the nipple. Ten women will be enrolled to check if the procedure can be done without switching to open surgery and how long it takes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) procedure
- What this could lead to
- If successful, this could offer a less invasive surgical option for breast cancer patients, with smaller scars and faster recovery.
- What could go wrong
- This is a very small pilot study with only 10 participants, so results may not apply broadly. The procedure requires specialized training and may not be feasible for 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
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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 * Candidates for nipple-sparing mastectomy (NSM) with immediate reconstruction * Histologically confirmed invasive carcinoma cT1N0, or carriers of pathogenic germline mutations undergoing prophylactic mastectomy * Breast size I-III and absence of significant glandular ptosis * Signed informed consent Exclusion Criteria: * Inflammatory breast cancer * Locally advanced clinical stage (cT2-T4 or N+) * Ductal carcinoma in situ (DCIS) without invasive component * Previous radiotherapy to the affected breast * Locoregional recurrence * Clinical conditions contraindicating prosthetic reconstruction * Indication for skin-sparing (SSM) or skin-reducing mastectomy (SRM) * Ongoing or completed neoadjuvant chemotherapy before surgery * Refusal or inability to sign informed consent * Inability to complete scheduled follow-up
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Istituto Europeo di Oncologia
RECRUITINGMilan, 20141, Italy
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