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

Status Active, not recruiting

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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