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Procedure

Open for Nipple Sparing Mastectomy (NSM Open Trial)

N/A
Recruiting
Research Sponsored by Intuitive Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative period through 42 days postoperatively
Awards & highlights

Summary

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative period through 42 days postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative period through 42 days postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness
Safety Endpoint: complication rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: OpenExperimental Treatment1 Intervention
Prophylactic NSM cases by Open approach
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipple Sparing Mastectomy
2009
N/A
~80

Find a Location

Who is running the clinical trial?

Intuitive SurgicalLead Sponsor
76 Previous Clinical Trials
49,530 Total Patients Enrolled
2 Trials studying Nipple Sparing Mastectomy
175 Patients Enrolled for Nipple Sparing Mastectomy
~4 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
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