To Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer

NCT ID: NCT06561646

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2028-12-31

Brief Summary

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The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the abdominal endoscopic surgery system and evaluate the effectiveness and safety of the single-port robotic-assisted breast surgery in breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-port robotic-assisted breast surgery

the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer; single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection

Group Type EXPERIMENTAL

single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy

Intervention Type PROCEDURE

the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer

single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection

Intervention Type PROCEDURE

the single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection in the management of breast cancer

Interventions

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single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy

the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer

Intervention Type PROCEDURE

single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection

the single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection in the management of breast cancer

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

1. Male breast cancer or inflammatory breast cancer;
2. Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
3. The clinical data is basically incomplete;
4. Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
5. Bilateral breast cancer surgery;
6. Other surgical methods;
7. Preoperative distant metastasis or supraclavicular lymph node dissection;
8. Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
9. The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
10. Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Qiang Ding, Professor

Role: CONTACT

+8613951731373

Facility Contacts

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Qiang Ding, Professor

Role: primary

+8613951731373

Other Identifiers

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BC-Robot-20240810

Identifier Type: -

Identifier Source: org_study_id

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