Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy

Nipple Sparing Mastectomy Clinical Trial

Official title:

A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03892980
• Other study ID #: ISI dV Xi-NSM
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: December 30, 2029

Study information

• Verified date: April 2024
• Source: Intuitive Surgical
• Contact: Tish Mikoczi
• Phone: 760-274-5811
• Email: NSM-Xi[@]intusurg.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Description:

Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex. This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: December 30, 2029
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Female between ages 18-80.
• BMI = 29.
• Candidate for an NSM procedure.
• At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side.
• Breast ptosis = Grade 2.
• Cup size = C.
• No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines.

Exclusion Criteria:

• Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery.
• Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior).
• Current history of smoking or has smoked within 1 year of screening.
• Skin conditions
• Uncontrolled diabetes mellitus.
• Previous chemotherapy or radiation
• High risk for anesthesia or significant medical comorbidities
• Contraindicated for general anesthesia or surgery.
• Known bleeding or clotting disorder.
• Pregnant or suspected to be pregnant or is lactating.

Related Conditions & MeSH terms

• Nipple Sparing Mastectomy

Intervention

Device:
• Nipple-Sparing Mastectomy
Nipple-sparing mastectomy using da Vinci Surgical Systems.

Locations

Country	Name	City	State
United States	NorthShore University Health System	Evanston	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Northwell Health	New Hyde Park	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of breast cancer	Occurrence and recurrence of breast cancer	Annual through 5 year post-operatively
Other	Patient reported outcomes	BREAST-Q	Pre-operatively, post-operatively at 42 days, annually through 5 years
Other	Long-term safety: incidence of adverse events	Incidence of breast procedure-related adverse events during long-term follow up	Annually through 5 years post-operatively
Primary	Primary Effectiveness: No conversions to open NSM	Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery	Assessed during surgery
Primary	Primary Safety: Incidence of adverse events	Incidence of intraoperative and post-operative procedure and device-related adverse events	Assessed during surgery to 42 days after surgery