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Robotic Surgery
Robotic vs. Open Mastectomy for Breast Cancer (SP NSM 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
Breast ptosis ≤ Grade 2
Diagnosis of early stage breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
SP NSM Trial Summary
This trial compares a robotic to a traditional surgical method for breast cancer-related surgery.
Who is the study for?
This trial is for women over 21 with a breast cup size of C or smaller, BMI under 30, diagnosed with early stage breast cancer and suitable for Nipple Sparing Mastectomy (NSM) with immediate reconstruction. It's not for those who've had previous breast surgery, are pregnant/breastfeeding, have bleeding/clotting disorders, prior chest radiation treatment, smoke currently or can't undergo general anesthesia.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of two types of mastectomy procedures: one using the da Vinci SP Surgical System (Robotic NSM) and the other traditional open surgery (Open NSM). The goal is to see which method might be better for patients undergoing nipple sparing mastectomies.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at the surgical site, infection risk from incisions, potential complications from anesthesia and possible differences in recovery time between robotic versus open surgery.
SP NSM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast sagging is mild to moderate.
Select...
I have been diagnosed with early stage breast cancer.
Select...
I am a woman aged 21 or older.
SP NSM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conversion rate
Safety: Adverse event rates
Safety: positive surgical margin rates
Secondary outcome measures
Oncological Outcomes (for cancer recurrence)
Oncological Outcomes (for disease-free survival)
Oncological Outcomes (for overall survival)
+3 moreSP NSM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Robotic NSM with da Vinci SPExperimental Treatment1 Intervention
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Group II: Open NSMActive Control1 Intervention
Subjects randomized to this arm will undergo conventional open NSM procedures
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Who is running the clinical trial?
Intuitive SurgicalLead Sponsor
73 Previous Clinical Trials
49,055 Total Patients Enrolled
Kathryn WineStudy DirectorIntuitive Surgical
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have general anesthesia or surgery due to health risks.My breast sagging is mild to moderate.I have been diagnosed with early stage breast cancer.You have a cup size smaller than C.I have had breast surgery before.I am a woman aged 21 or older.I am eligible for nipple-sparing mastectomy with immediate reconstruction.You weigh less than 30% more than what is considered healthy for your height.I have a known bleeding or clotting disorder.I have had radiation treatment to my chest before.You are currently smoking cigarettes.My breast cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Open NSM
- Group 2: Robotic NSM with da Vinci SP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies available for participants in this research endeavor?
"Clinicaltrials.gov reports that this particular medical experiment is not presently accepting applicants, despite its initial posting date of April 1st 2023 and last update on March 15th 2023. However, there are currently 2625 other clinical trials with open enrollment at the moment."
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