Breast Cancer Clinical Trial

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Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy

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Summary

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

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Full 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 Xi Surgical System in NSM procedures.

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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.
Breast ptosis ≤ Grade 2.
Cup size ≤ C.
No presence of occult cancer 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.
Previous breast surgery of the ipsilateral breast
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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

145

Study ID:

NCT03892980

Recruitment Status:

Recruiting

Sponsor:

Intuitive Surgical

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There are 6 Locations for this study

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Mayo Clinic Florida
Jacksonville Florida, 32224, United States More Info
Amanda Arnold
Contact
James Jakub, MD
Principal Investigator
NorthShore University Health System
Evanston Illinois, 60201, United States More Info
Sarah Rabbitt, RN
Contact
Katherine Kopkash, MD
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Jennifer Krogman
Contact
Mara Piltin, DO
Principal Investigator
Northwell Health
New Hyde Park New York, 11040, United States More Info
Kirendra Pasram
Contact
Alan Kadison, MD
Principal Investigator
University of Pennsylvania
Philadelphia Pennsylvania, 19107, United States More Info
Ari Brooks, MD
Contact
Ari Brooks, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Rosa Hwang, MD
Contact
Rosa Hwang, MD
Principal Investigator
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

145

Study ID:

NCT03892980

Recruitment Status:

Recruiting

Sponsor:


Intuitive Surgical

How clear is this clinincal trial information?

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