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Active Not RecruitingNCT04537312

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Ohio State University Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDURERobot-assisted Nipple Sparing MastectomyUnder RNSM
OTHERSurvey Administrationancillary correlative
DEVICERNSMRobot-assisted Nipple Sparing Mastectomy

Timeline

Start date
2020-11-17
Primary completion
2025-10-31
Completion
2026-10-31
First posted
2020-09-03
Last updated
2025-12-22

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04537312. Inclusion in this directory is not an endorsement.