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Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)

Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial

Official title:
Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)

Clinical Trial Summary

This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.

Clinical Trial Description

With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel. This is a single-arm pilot study for feasibility and safety of RNSM. ;

Study Design

Related Conditions & MeSH terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Breast Carcinoma In Situ
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Ductal, Breast
  • Carcinoma, Intraductal, Noninfiltrating
  • Ductal Breast Carcinoma In Situ
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prophylactic Mastectomy
Clinical Trial Details
NCT number NCT04537312
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Active, not recruiting
Phase N/A
Start date November 17, 2020
Completion date December 31, 2024
View Details
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