Robotic-Assisted da Vinci System Prophylactic Nipple-Spar... | NCT03892980

Studies
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

NCT03892980

Sponsor

Intuitive Surgical

Status

Active, not recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

145Estimated

Phase

Not Applicable

Conditions

Nipple Sparing Mastectomy

Interventions

Nipple-Sparing Mastectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2021Actual

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

Dec 30, 2029Estimated

First Submitted Date

Mar 21, 2019

First Submission Date that Met QC Criteria

Mar 26, 2019

First Posted Date

Mar 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nipple Sparing Mastectomy	Experimental		Device: Nipple-Sparing Mastectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nipple-Sparing Mastectomy	Device	Nipple-sparing mastectomy using da Vinci Surgical Systems.	Nipple Sparing Mastectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Incidence of breast cancer	Occurrence and recurrence of breast cancer	Annual through 5 year post-operatively
Patient reported outcomes	BREAST-Q

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Florida		Jacksonville	Florida	32224	United States
NorthShore University Health System

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative