Anatomic Stage I Breast Cancer AJCC v8NCT04537312
Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
A study testing Robot-assisted Nipple Sparing Mastectomy, Survey Administration and RNSM in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Robot-assisted Nipple Sparing Mastectomy, Survey Administration and RNSM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)
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.
Read the detailed description
With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel.
This is a single-arm pilot study for feasibility and safety of RNSM.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Robot-assisted Nipple Sparing Mastectomy, Survey Administration, RNSM
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted Nipple Sparing MastectomyProcedure or surgery
Under RNSM
Survey AdministrationOther
ancillary correlative
RNSMDevice
Robot-assisted Nipple Sparing Mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (RNSM, surveys) | Experimental | RNMS Surveys Receives: Procedure: Robot-assisted Nipple Sparing Mastectomy; Other: Survey Administration; Device: RNSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of removal of breast gland en bloc through RNSM
Measure number of patients who had breast removed en bloc through RNSM incision.
Measured: Up to 1 year
Complication rate of patients with bleeding requiring re-operation
Number of patients with bleeding requiring re-operation after RNSM.
Measured: Up to 1 year
Complication rate of patients with infection requiring antibiotics or re-operation
Number of patients with infection after surgery requiring antibiotics or re-operation.
Measured: Up to 1 year
Complication rate of patients with Mastectomy flap (SKIN flap score)
Number of patients with mastectomy flap or nipple-areolar complex necrosis as measured using the SKIN flap score after surgery. Score of A1 indicates normal skin, D4 indicates total full thickness necrosis.
Measured: Up to 1 year
Perioperative Outcomes investigating the total duration of surgical time
Investigate the total duration of the operation (surgical time data),
Measured: Up to 1 year
Perioperative Outcomes investigating length of surgery time
Investigate the total duration of the operation (surgical time data) of each patient
Measured: Up to 1 year
Perioperative Outcomes investigating the length of hospitalization
Investigate the length of hospitalization for each patient
Measured: Up to 1 year
Secondary outcomes (4)
Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey
Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery.
Measured: Up to 1 year
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire
Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery.
Measured: Up to 1 year
Patient Reported Outcomes
Monofilament testing to test for sensation recovery after surgery from each participant. Semmes Weinstein monofilament exam; sensation to series of monofilament with different thickness, compare sensation to preoperative exam.
Measured: Up to 1 year
Patient Reported Outcomes
Patient satisfaction with the breast after surgery measured by BREAST-Q survey. Lowest score = 0, highest = 100 with higher scores indicating better outcomes / quality of life.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start17 Nov 2020
- Primary completion31 Oct 2025
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Myers, Ohio State University Comprehensive Cancer Center
- Investigators
- William Carson, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537312
- Sponsor's protocol ID
- OSU-19199
- Other IDs
- NCI-2020-05349
- Status last verified
- Dec 2025
- First submitted
- 18 Aug 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Park KU, Lee S, Sarna A, Chetta M, Schulz S, Agnese D, Grignol V, Carson W, Skoracki RJ. Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). BMJ Open. 2021 Nov 15;11(11):e050173. doi: 10.1136/bmjopen-2021-050173.
PubMed 34782341
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)
- ClinicalTrials.gov ID
- NCT04537312
- Acronym / sponsor ID
- OSU-19199
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel.
This is a single-arm pilot study for feasibility and safety of RNSM.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (RNSM, surveys) | Experimental | Procedure: Robot-assisted Nipple Sparing Mastectomy, Other: Survey Administration, Device: RNSMRNMS Surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Surgical candidates, per standard of care for:
- 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
Key exclusion criteria (12 listed)
- Pregnant or nursing women
- Patients with:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted Nipple Sparing MastectomyUnder RNSM | Procedure or surgery | Supportive care (RNSM, surveys) |
| Survey Administrationancillary correlative | Other | Supportive care (RNSM, surveys) |
| RNSMRobot-assisted Nipple Sparing Mastectomy | Device | Supportive care (RNSM, surveys) |
Primary outcome
Feasibility of removal of breast gland en bloc through RNSM
Time frame: Up to 1 year
Measure number of patients who had breast removed en bloc through RNSM incision.
Complication rate of patients with bleeding requiring re-operation
Time frame: Up to 1 year
Number of patients with bleeding requiring re-operation after RNSM.
Complication rate of patients with infection requiring antibiotics or re-operation
Time frame: Up to 1 year
Number of patients with infection after surgery requiring antibiotics or re-operation.
Complication rate of patients with Mastectomy flap (SKIN flap score)
Time frame: Up to 1 year
Number of patients with mastectomy flap or nipple-areolar complex necrosis as measured using the SKIN flap score after surgery. Score of A1 indicates normal skin, D4 indicates total full thickness necrosis.
Perioperative Outcomes investigating the total duration of surgical time
Time frame: Up to 1 year
Investigate the total duration of the operation (surgical time data),
Perioperative Outcomes investigating length of surgery time
Time frame: Up to 1 year
Investigate the total duration of the operation (surgical time data) of each patient
Perioperative Outcomes investigating the length of hospitalization
Time frame: Up to 1 year
Investigate the length of hospitalization for each patient
4 secondary outcomes
Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey
Time frame: Up to 1 year
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire
Time frame: Up to 1 year
Patient Reported Outcomes
Time frame: Up to 1 year
Patient Reported Outcomes
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 34782341Park KU, Lee S, Sarna A, Chetta M, Schulz S, Agnese D, Grignol V, Carson W, Skoracki RJ. Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). BMJ Open. 2021 Nov 15;11(11):e050173. doi: 10.1136/bmjopen-2021-050173.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Carson, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted Nipple Sparing Mastectomy, Survey Administration and RNSM in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of removal of breast gland en bloc through RNSM (time frame: Up to 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.