Robots take on breast cancer surgery in tiny pilot trial
NCT ID NCT04537312
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested whether a robot-assisted surgical technique (using the daVinci system) can safely remove breast tissue while sparing the nipple in people with early-stage breast cancer or those needing preventive mastectomy. Only 4 participants were enrolled, and the study focused on feasibility, surgical time, and complications like bleeding or infection. Because it is very small and early, the results are preliminary and not yet generalizable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Robot-assisted nipple sparing mastectomy (using the daVinci surgical system)
- What this could lead to
- If successful, this could show that robot-assisted mastectomy is safe and feasible, potentially offering a less invasive surgical option for some breast cancer patients.
- What could go wrong
- This is a very small pilot study with only 4 participants, so results may not apply widely. The procedure is still experimental and risks like bleeding, infection, or skin necrosis are being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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4 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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