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Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy

NCT05448963 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-25

No results posted yet for this study

Summary

Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. Robot-assisted mastectomy enables removal of the whole breast tissue with well-preserved breast skin envelope through a single longitudinal incision in the anterior axillary line at the nipple areolar level. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which is likely to improve the efficacy of robotic mastectomy. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. Participants with breast cancer indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations are recruited to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility, and the secondary endpoint is safety and patient-reported outcome.

Conditions

  • Nipple-sparing Mastectomy
  • Prophylactic Mastectomy
  • Breast Cancer
  • BRCA1 Mutation
  • BRCA2 Mutation

Interventions

DEVICE

da Vinci SPⓇ Single-port System

Nipple-sparing mastectomy with or without axillary lymph node dissection using da Vinci SP single-port system

Sponsors & Collaborators

  • Intuitive Surgical

    collaborator INDUSTRY

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Wen-Ling Kuo, MD. PhD. · Breast Cancer Center, Chang Gone Memorial Hospital , Linkou Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-07-30
Primary Completion
2023-06-30
Completion
2023-08-01
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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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 NCT05448963 on ClinicalTrials.gov