Open Nipple Sparing Mastectomy (NSM) | NCT04447339

Studies
Open Nipple Sparing Mastectomy (NSM)

NCT04447339

Sponsor

Intuitive Surgical

Status

Active, not recruiting

Last Update Posted

Mar 24, 2026Actual

Enrollment

75Estimated

Phase

Not provided

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

Mar 2026

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

Sep 21, 2020Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jun 16, 2020

First Submission Date that Met QC Criteria

Jun 23, 2020

First Posted Date

Jun 25, 2020Actual

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

Mar 20, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Detailed Description

This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open		Prophylactic NSM cases by Open approach	Procedure: Nipple Sparing Mastectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nipple Sparing Mastectomy	Procedure	Prophylactic open NSM procedures	Open

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Endpoint: complication rate	To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures	IntraOperative period through 42 days postoperatively
Effectiveness	Ability to completely excise memory gland tissue and preserve Nipple Areola Complex	IntraOperative period through 42 days postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive subjects that have undergone open NSM procedures for prophylaxis between January 1 2018 through 42 days prior to IRB approval will be included in this retrospective chart review.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NorthShore University Health System		Evanston	Illinois	60201	United States
Mayo Clinic Hosp - Methodist Campus - MN

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015414	Mastectomy, Subcutaneous

Ancestor Terms

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided