NSM Open: Open Nipple Sparing Mastectomy (NSM)
Sponsor
Intuitive Surgical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04447339
Collaborator
(none)
75
5
22.3
15
0.7
Study Details
Study Description
Brief Summary
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
Study Design
Study Type:
Observational
Anticipated Enrollment
:
75 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)
Actual Study Start Date
:
Sep 21, 2020
Anticipated Primary Completion Date
:
May 30, 2022
Anticipated Study Completion Date
:
Jul 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Open Prophylactic NSM cases by Open approach |
Procedure: Nipple Sparing Mastectomy
Prophylactic open NSM procedures
|
Outcome Measures
Primary Outcome Measures
- Safety Endpoint: complication rate [IntraOperative period through 42 days postoperatively]
To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures
- Effectiveness [IntraOperative period through 42 days postoperatively]
Ability to completely excise memory gland tissue and preserve Nipple Areola Complex
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NorthShore University Health System | Evanston | Illinois | United States | 60201 |
| 2 | Mayo Clinic Hosp - Methodist Campus - MN | Rochester | Minnesota | United States | 55905 |
| 3 | Northwell Health | Queens | New York | United States | 11040 |
| 4 | Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 5 | Univ. of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT04447339
Other Study ID Numbers:
- ISI-RoNSM-01
First Posted:
Jun 25, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No