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Not yet recruitingNCT07879963Updated Oct 19, 2026

Safety and Effectiveness Study of Single-Port Surgical System in Breast Tumor Surgery

An interventional study of Robotic-assisted breast tumor surgery and Single-port surgical system operation in Breast Neoplasms, sponsored by haiyanli. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by haiyanli · Not applicable, Interventional, and Treatment

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Breast Neoplasms

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03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 25 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with haiyanli as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

  • 1. Female patients aged 18-75 years;

    2. Clinically diagnosed breast cancer requiring surgical treatment;

    3. Suitable for robotic-assisted breast surgery;

    4. Able to understand and sign the informed consent form voluntarily.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Robotic-assisted Single-port Breast Tumor Surgery

    Device: Robotic-assisted breast tumor surgery · Procedure: Single-port surgical system operation

Interventions

  • DeviceRobotic-assisted breast tumor surgery

    Robotic resection of breast tumor performed with single-port thoracoscopic and abdominal endoscopic surgical system.

  • ProcedureSingle-port surgical system operation

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Intraoperatively (during surgery)

  2. 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.

    Time frame: 1 year after surgery

Secondary outcomes

  1. Operative time

    Total operative time from skin incision to the completion of wound closure during robotic breast tumor resection.

    Time frame: Perioperative

  2. Intraoperative blood loss

    The volume of blood loss measured during robotic breast tumor resection surgery. Operation duration

    Time frame: Perioperative

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07879963
Lead sponsor
haiyanli
Responsible party
haiyanli (Attending Surgeon, Guangzhou Women and Children's Medical Center) — Sponsor-investigator
First posted
Oct 19, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Haiyan Li, MD
Contact
lihaiyan@gwcmc.org
86-15813340604

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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