Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
204 participants
INTERVENTIONAL
2023-05-08
2030-12-31
Brief Summary
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Detailed Description
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This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic NSM with da Vinci SP
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Robotic NSM
Robotic-assisted Nipple sparing mastectomy procedures
Open NSM
Subjects randomized to this arm will undergo conventional open NSM procedures
Open NSM
open nipple-sparing mastectomy procedures
Interventions
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Robotic NSM
Robotic-assisted Nipple sparing mastectomy procedures
Open NSM
open nipple-sparing mastectomy procedures
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \< 30
* Candidate for an NSM procedure with immediate reconstruction
* Diagnosis of early stage brest cancer
* Breast ptosis ≤ Grade 2.
* Cup size ≤ C.
Exclusion Criteria
* Diagnosis of metastatic breast cancer
* Prior radiation treatment to the chest
* Current smokers
* Contraindication for general anesthesia or surgery.
* Known bleeding or clotting disorder.
* Pregnant or suspected to be pregnant, or actively breastfeeding
21 Years
FEMALE
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Principal Investigators
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Madhu Gorrepati
Role: STUDY_DIRECTOR
Intuitive
Locations
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City of Hope
Irvine, California, United States
Cedars-Sinai
Los Angeles, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Endeavor Health
Evanston, Illinois, United States
Corewell
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University, St. Louis
St Louis, Missouri, United States
Northwell Health
Lake Success, New York, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Ascension St. Columbia Mary's
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ISI dV SP - NSM-01
Identifier Type: -
Identifier Source: org_study_id