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New treatment option for Breast Cancer - Ductal Carcinoma in Situ (DCIS)
Official title Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer
ClinicalTrials.gov ID: NCT07507890
What this study is testing
- What it's testing
- This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female participants aged 18 years or older.
- Diagnosis of early-stage invasive breast cancer or ductal carcinoma in situ, including multifocal or multicentric disease.
- Candidate for nipple-sparing mastectomy with immediate direct-to-implant reconstruction.
- Small- to medium-sized breasts with ptosis grade 2 or less.
- Written informed consent provided.
You likely can't join if
- Preoperative evidence of skin involvement, nipple-areola complex involvement, lymph-node metastases, inflammatory breast cancer, Paget's disease...
- Previous ipsilateral breast surgery.
- Previous thoracic radiation therapy.
- Heavy smoking (\>20 cigarettes/day), uncontrolled diabetes mellitus, or body mass index \>30.
- ASA score 3 or higher.
- Ongoing pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Candiolo, Turin, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Candiolo, Turin, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.