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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05720039
Other study ID # ISI dV SP - NSM-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date December 2026

Study information

Verified date March 2024
Source Intuitive Surgical
Contact Kathryn Wine
Phone 415-990-4104
Email Kathryn.Wine@Intusurg.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.


Description:

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM. This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.


Recruitment information / eligibility

Status Recruiting
Enrollment 204
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria: - Female age 21 or older - BMI < 30 - Candidate for an NSM procedure with immediate reconstruction - Diagnosis of early stage brest cancer - Breast ptosis = Grade 2. - Cup size = C. Exclusion Criteria: - Previous breast surgery - Diagnosis of metastatic breast cancer - Prior radiation treatment to the chest - Current smokers - Contraindication for general anesthesia or surgery. - Known bleeding or clotting disorder. - Pregnant or suspected to be pregnant, or actively breastfeeding

Study Design


Intervention

Device:
Robotic NSM
Robotic-assisted Nipple sparing mastectomy procedures
Procedure:
Open NSM
open nipple-sparing mastectomy procedures

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Corewell Detroit Michigan
United States City of Hope Duarte California
United States Duke University Durham North Carolina
United States NorthShore University HealthSystem Evanston Illinois
United States MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Florida Jacksonville Florida
United States Northwell Health Lake Success New York
United States Cedars-Sinai Los Angeles California
United States Ascension St. Columbia Mary's Milwaukee Wisconsin
United States Vanderbilt Nashville Tennessee
United States University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Rochester Rochester Minnesota
United States Washington University, St. Louis Saint Louis Missouri
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Conversion rate Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery Assessed during procedure
Primary Safety: Adverse event rates Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM Up to 42 days post-operatively
Primary Safety: positive surgical margin rates Incidence of positive surgical margins compared to open NSM Up to 42 days post-operatively
Secondary Oncological Outcomes (for cancer recurrence) Recurrence Up to 5 years
Secondary Oncological Outcomes (for disease-free survival) Disease-free survival Up to 5 years
Secondary Oncological Outcomes (for overall survival) Overall survival Up to 5 years
Secondary Patient-Report Outcomes (BREAST-Q) BREAST-Q Up to 5 years
Secondary Patient-Report Outcomes (NAC Questionnaire) NAC Questionnaire Up to 5 years
Secondary Patient-Report Outcomes (EQ-5D) EQ-5D Up to 1 year
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