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NCT07781163 · ClinicalTrials.gov record · last posted 2026-08-24

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

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-12-30
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07781163
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Breast Cancer
Enrollment 30 participants
Start Date 2026-12-30
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-24