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Robotic Nipple-Sparing Mastectomy for Breast Cancer
Study Summary
This trial is designed to track outcomes of patients who undergo a new type of breast cancer surgery using a single-port robotic platform. The surgery, called robotic nipple-sparing mastectomy (rNSM), involves removing the breast tissue and reconstructing the breast using tissue expanders/implants and acellular dermal matrix (ADM). The trial will measure safety, feasibility, oncological outcomes, and patient satisfaction. The hypothesis is that SPr-NSM is equal to or better than open NSM in terms of safety, feasibility, and oncological outcomes, with improved patient satisfaction as measured by nipple sensation and patient-
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your nipples sag a lot.You have tumors that have spread to your skin.You are not able to have general anesthesia or surgery.You currently smoke a lot, more than 20 cigarettes per day.You are able to perform daily activities without being limited by your health condition (ECOG performance status 0 or 1).You have been diagnosed with a tumor involving the nipple areolar complex before surgery.You are not eligible if you are planning to have a certain type of breast surgery for risk reduction or treatment of breast cancer.You have inflammatory breast cancer.
- Group 1: Treatment arm (SPrNSM)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What key goals are researchers striving to accomplish with this investigation?
"During this clinical trial, the primary endpoint of evaluation is the rate of perioperative complications. Secondary metrics include degree to which patients maintain nipple sensation using Semmes Weinstein monofilament tool at baseline and postoperatively; number of participants with new breast cancers; and incidence of long-term complications evaluated over 5 years using NCI CTACAE v. 4.03 criteria for Grade 3,4 or 5 events."
Are there still opportunities to enroll in this investigation?
"According to clinicaltrials.gov, this medical trial is currently enrolling patients and was first listed on 8th March 2022 with the last update occurring a fortnight later on 21st March 2022."
Does the eligibility criterion for this study include individuals under twenty years of age?
"Per the requirements for joining this clinical trial, potential participants must have attained a minimum age of 18 and not exceed 80 years old."
Are there any specific eligibility criteria for individuals to join this investigation?
"This clinical trial is seeking 90 participants with a history of breast cancer, aged between 18 and 80. Crucially, candidates should meet the following criteria: Eligible for open nipple-sparing mastectomy according to accepted anatomical standards; prophylactic resection or treatment of ductal carcinoma in situ/clinically node negative cT1-T3 tumors; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1."
To what extent is the sample size of this clinical trial expanding?
"Affirmative, the information made available on clinicaltrials.gov suggests that this research is actively recruiting test subjects. It was initially published on March 8th 2022 and has been updated most recently on March 21st 2022. This study requires 90 participants to be recruited at 1 medical facility."
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