Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-sparing Matectomy With Reconstruction in Early-Stage Breast Cancer Patients

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT07781163
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • single-port robot-assisted surgery — PROCEDURE
    All enrolled participants will receive single-port robot-assisted endoscopic breast cancer surgery. Patient will receive either breast-conserving surgery (BCS) or nipple-sparing mastectomy with immediate prosthetic reconstruction depending on the tumor burden.

Study Details

This study is testing a new, less invasive way to perform breast cancer surgery using a single-port robotic system (a robot-assisted surgical tool made in China, called the Shurui SR-ENS-600). The robot works through one small hidden incision (about 3-4 cm) in the armpit or under the breast fold, instead of multiple cuts or a large open wound. We want to find out whether this robot-assisted surgery is safe and effective for women with early-stage breast cancer who need either: Breast-conserving surgery (lumpectomy), or Total removal of breast tissue with immediate reconstruction using a breast implant. You may be able to join if you: Are a woman aged 18-70 years; Have been diagnosed with early-stage breast cancer (by biopsy); Are suitable for either breast-conserving surgery or mastectomy with immediate implant reconstruction; Are in good general health (able to tolerate surgery and anesthesia); Are willing to receive the robotic surgery and complete the follow-up visits. If you join, you will: Receive the robotic surgery as your main treatment; Stay in the hospital for a short period after surgery (about 1-7 days); Come back for follow-up visits at 1, 3, 6, 12, and 24 months after surgery; Be asked to complete a few simple questionnaires about your recovery, satisfaction with breast appearance, and quality of life.

Key Dates

First listed
Aug 24, 2026
Start date
Dec 30, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single-port
    Patients in this arm will have single-port robot-assisted breast surgery

Primary Outcome Measure

Surgical success rate [ Time Frame: Perioperative ]

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