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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

NCT07781163 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

single-port robot-assisted surgery

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.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-30
Primary Completion
2026-12-30
Completion
2026-12-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781163 on ClinicalTrials.gov