Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM) (NCT04537312) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
United States4 participantsStarted 2020-11-17
Plain-language summary
This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Surgical candidates, per standard of care for:
* Nipple sparing resection and reconstruction OR
* Prophylactic mastectomy for risk reduction mastectomy OR
* Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
* Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
* Pregnant or nursing women
* Patients with:
* Inflammatory breast cancer
* Skin involvement with tumor
* Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor
* Grade 3 ptosis of nipple
* Smokers with heavy current use of nicotine (defined as \> 20 cigarettes/day)
* Patients that are high risk for anesthesia, as documented in medical record
* Patients that do not have the ability to give informed consent
* Prisoner status at surgical clinic visit
* Bra cup size greater than C cup
* Previous thoracic radiation history (for any reason)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of removal of breast gland en bloc through RNSM
Timeframe: Up to 1 year
2
Complication rate of patients with bleeding requiring re-operation
Timeframe: Up to 1 year
3
Complication rate of patients with infection requiring antibiotics or re-operation
Timeframe: Up to 1 year
4
Complication rate of patients with Mastectomy flap (SKIN flap score)
Timeframe: Up to 1 year
5
Perioperative Outcomes investigating the total duration of surgical time
Timeframe: Up to 1 year
6
Perioperative Outcomes investigating length of surgery time
Timeframe: Up to 1 year
7
Perioperative Outcomes investigating the length of hospitalization
Timeframe: Up to 1 year
Trial details
NCT IDNCT04537312
SponsorOhio State University Comprehensive Cancer Center