Breast NeoplasmsNCT07879963
Safety and Effectiveness Study of Single-Port Surgical System in Breast Tumor Surgery
A study testing Robotic-assisted breast tumor surgery and Single-port surgical system operation in people with Breast Neoplasms, run by haiyanli.
Trial summary
This is a prospective, multicenter clinical study designed to evaluate the safety and effectiveness of remote surgery using the single-port thoracoabdominal endoscopic surgical system in breast tumor surgery. Eligible patients diagnosed with breast tumors will receive robotic-assisted remote surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Robotic-assisted breast tumor surgery and Single-port surgical system operation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
- 1. Female patients aged 18-75 years;
- Clinically diagnosed breast cancer requiring surgical treatment;
- Suitable for robotic-assisted breast surgery;
- Able to understand and sign the informed consent form voluntarily.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Clinical Study on Safety and Effectiveness of Single-Port Thoracoscopic and Laparoscopic Surgical System in Breast Tumor Surgery
This is a prospective, multicenter clinical study designed to evaluate the safety and effectiveness of remote surgery using the single-port thoracoabdominal endoscopic surgical system in breast tumor surgery. Eligible patients diagnosed with breast tumors will receive robotic-assisted remote surgery. The primary endpoints include safety indicators and surgical effectiveness parameters. The study aims to provide clinical evidence for the application of this surgical system in breast cancer treatment.
- Conditions
- Breast Neoplasms
- Being tested
- Robotic-assisted breast tumor surgery, Single-port surgical system operation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted breast tumor surgeryDevice
Robotic resection of breast tumor performed with single-port thoracoscopic and abdominal endoscopic surgical system.
Single-port surgical system operationProcedure or surgery
Retrospective observational analysis of patients who underwent breast surgery via single-port surgical system. This study collects historical clinical data to evaluate clinical efficacy and safety outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted Single-port Breast Tumor Surgery | Experimental | Not described Receives: Device: Robotic-assisted breast tumor surgery; Procedure: Single-port surgical system operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversion to open surgery
The proportion of participants requiring intraoperative conversion from laparoscopic breast tumor surgery to open surgery for any reason during the index operation
Measured: Intraoperatively (during surgery)
Progression-free survival (PFS)
The time from the date of surgery to the first occurrence of local recurrence, distant metastasis, or death from any cause. Patients without events will be censored at the last follow-up.
Measured: 1 year after surgery
Secondary outcomes (2)
Operative time
Total operative time from skin incision to the completion of wound closure during robotic breast tumor resection.
Measured: Perioperative
Intraoperative blood loss
The volume of blood loss measured during robotic breast tumor resection surgery.
Operation duration
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- haiyanli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, haiyanli, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879963
- Sponsor's protocol ID
- C-600-KY-202604-001
- Other IDs
- SuiFuPed Ethics[2026]No.322A01
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on Safety and Effectiveness of Single-Port Thoracoscopic and Laparoscopic Surgical System in Breast Tumor Surgery
- ClinicalTrials.gov ID
- NCT07879963
- Acronym / sponsor ID
- C-600-KY-202604-001
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- haiyanliUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter clinical study designed to evaluate the safety and effectiveness of remote surgery using the single-port thoracoabdominal endoscopic surgical system in breast tumor surgery. Eligible patients diagnosed with breast tumors will receive robotic-assisted remote surgery. The primary endpoints include safety indicators and surgical effectiveness parameters. The study aims to provide clinical evidence for the application of this surgical system in breast cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted Single-port Breast Tumor Surgery | Experimental | Device: Robotic-assisted breast tumor surgery, Procedure: Single-port surgical system operation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted breast tumor surgeryRobotic resection of breast tumor performed with single-port thoracoscopic and abdominal endoscopic surgical system. | Device | Robotic-assisted Single-port Breast Tumor Surgery |
| Single-port surgical system operationRetrospective observational analysis of patients who underwent breast surgery via single-port surgical system. This study collects historical clinical data to evaluate clinical efficacy and safety outcomes. | Procedure or surgery | Robotic-assisted Single-port Breast Tumor Surgery |
Primary outcome
Rate of conversion to open surgery
Time frame: Intraoperatively (during surgery)
The proportion of participants requiring intraoperative conversion from laparoscopic breast tumor surgery to open surgery for any reason during the index operation
Progression-free survival (PFS)
Time frame: 1 year after surgery
The time from the date of surgery to the first occurrence of local recurrence, distant metastasis, or death from any cause. Patients without events will be censored at the last follow-up.
2 secondary outcomes
Operative time
Time frame: Perioperative
Intraoperative blood loss
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted breast tumor surgery and Single-port surgical system operation in people with Breast Neoplasms, run by haiyanli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Li, MD (86-15813340604, lihaiyan@gwcmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of conversion to open surgery (time frame: Intraoperatively (during surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.