Endoscopic Video-assisted Nipple-sparing MastectomyEVANCT07579117
Endoscopic Video-Assisted Nipple-Sparing Mastectomy
A study testing Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) in people with Endoscopic Video-assisted Nipple-sparing Mastectomy and Breast Surgery, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endoscopic Video-assisted Nipple-sparing Mastectomy, Breast Surgery, Breast Cancer
- What is being tested?
- Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
Eleonora Meduri, MD, +39 02 57489 725, eleonora.meduri@ieo.it
Eleonora Meduri, MD
About this study
Official title: EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.
Read the detailed description
This pilot study aims to prospectively document the technical feasibility and perioperative outcomes of E-NSM performed according to an established institutional protocol, including standardized perfusion assessment using indocyanine green (ICG) angiography and patient-reported outcomes using BREAST-Q questionnaire. Data generated from this study will support refinement of the institutional protocol and inform the design of future comparative or multicentre trials.
- Being tested
- Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)Procedure or surgery
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. Recent prospective studies and meta-analyses have shown encouraging results in terms of technical feasibility, reduced flap-related complications, and higher patient satisfaction compared with the conventional open approach.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) | Experimental | All enrolled patients will undergo endoscopic video-assisted nipple-sparing mastectomy (E-NSM) with immediate breast reconstruction (implant-based or pre-planned alternative reconstruction). Receives: Procedure: Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of completion of the procedure endoscopically without conversion to open surgery.
Number of procedure not converted to open surgery on the total of study procedures.
Measured: At surgery
Surgery time
Average and median duration of endoscopic dissection, including creation of the working space.
Measured: At surgery
Feasibility of immediate reconstruction
The feasibility and type of immediate reconstruction performed (direct-to-implant or two stage) measured as the number immediate rescotruction on the number of total surgery performed.
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start23 May 2026
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Video-assisted Nipple-sparing MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579117
- Sponsor's protocol ID
- UID 5184
- Other IDs
- L2-605
- Acronym
- EVA
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study
- ClinicalTrials.gov ID
- NCT07579117
- Acronym / sponsor ID
- EVA / UID 5184
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 23 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.
Detailed description
This pilot study aims to prospectively document the technical feasibility and perioperative outcomes of E-NSM performed according to an established institutional protocol, including standardized perfusion assessment using indocyanine green (ICG) angiography and patient-reported outcomes using BREAST-Q questionnaire. Data generated from this study will support refinement of the institutional protocol and inform the design of future comparative or multicentre trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) | Experimental | Procedure: Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)All enrolled patients will undergo endoscopic video-assisted nipple-sparing mastectomy (E-NSM) with immediate breast reconstruction (implant-based or pre-planned alternative reconstruction). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. Recent prospective studies and meta-analyses have shown encouraging results in terms of technical feasibility, reduced flap-related complications, and higher patient satisfaction compared with the conventional open approach. | Procedure or surgery | Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) |
Primary outcome
Rate of completion of the procedure endoscopically without conversion to open surgery.
Time frame: At surgery
Number of procedure not converted to open surgery on the total of study procedures.
Surgery time
Time frame: At surgery
Average and median duration of endoscopic dissection, including creation of the working space.
Feasibility of immediate reconstruction
Time frame: At surgery
The feasibility and type of immediate reconstruction performed (direct-to-implant or two stage) measured as the number immediate rescotruction on the number of total surgery performed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) in people with Endoscopic Video-assisted Nipple-sparing Mastectomy and Breast Surgery, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Meduri, MD (+39 02 57489 725, eleonora.meduri@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of completion of the procedure endoscopically without conversion to open surgery. (time frame: At surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.