One tiny incision: could robotic surgery transform breast cancer treatment?

NCT ID NCT07781163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial is investigating whether a single-port robotic system can safely and effectively perform breast cancer surgery through one small hidden incision, instead of larger cuts. The study includes women aged 18-80 with early-stage breast cancer who are candidates for either breast-conserving surgery or nipple-sparing mastectomy with immediate implant reconstruction. Participants will undergo the robotic procedure and be followed for two years to assess surgical success, recovery, and satisfaction with breast appearance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
single-port robot-assisted endoscopic surgery (using the Shurui SR-ENS-600 system) for breast-conserving surgery or nipple-sparing mastectomy with immediate implant reconstruction
What this could lead to
If successful, this approach could offer women with early-stage breast cancer a less invasive surgical option with smaller hidden scars, potentially improving recovery and cosmetic satisfaction.
What could go wrong
This is a small, early-stage study (30 participants) at one center. The robotic technique may not be suitable for all tumors, and there are risks of complications or the need to convert to open surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female patients aged 18 to 80 years; 2. Histopathologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS); 3. Clinical stage I-II for breast-conserving surgery, or clinical stage I-III for subcutaneous mastectomy with immediate prosthetic reconstruction; 4. Planned to undergo breast-conserving surgery or subcutaneous mastectomy with immediate prosthetic reconstruction; 5. For breast-conserving surgery: maximum tumor diameter ≤ 3 cm, with a favorable tumor-to-breast volume ratio for breast conservation; 6. For subcutaneous mastectomy with immediate prosthetic reconstruction: willingness and appropriate indication for prosthetic reconstruction, with moderate breast volume; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 8. American Society of Anesthesiologists (ASA) physical status classification I-III; 9. Adequate vital organ function meeting the following criteria: Hematology: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 90 × 10⁹/L, hemoglobin ≥ 90 g/L; Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5 × ULN; Renal function: creatinine ≤ 1.5 × ULN; Coagulation function: INR ≤ 1.5, APTT ≤ 1.5 × ULN; 10. Voluntary participation with written informed consent signed. Exclusion Criteria: 1. Prior history of breast surgery (excluding biopsy procedures); 2. Prior history of chest wall radiotherapy; 3. Pregnant or lactating women; 4. Concurrent malignancy (excluding adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); 5. Severe cardiopulmonary dysfunction precluding tolerance to general anesthesia; 6. Severe hepatic or renal insufficiency; 7. Coagulation disorders or ongoing anticoagulant therapy that cannot be discontinued; 8. Active infection, particularly in the breast region; 9. Allergy or intolerance to silicone implant materials (for patients undergoing prosthetic reconstruction); 10. Severe breast ptosis or excessively large breast volume (for patients undergoing prosthetic reconstruction); 11. Presence of any contraindication to surgery, or any condition that the investigator deems unsuitable for study participation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.