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Breast CancerNCT05245812

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A study testing da Vinci SP Surgical System in people with Breast Cancer and High Risk of Breast Cancer, run by Deborah Farr, MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Breast Cancer, High Risk of Breast Cancer
What is being tested?
da Vinci SP Surgical System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
8 Mar 2022to Feb 2027
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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing resection and resection OR prophylactic mastectomy for risk reduction OR treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Who cannot join

  • Inability to provide informed consent
  • Pregnant or nursing women
  • Patients with:
  • Inflammatory breast cancer
  • Skin involvement with tumor
  • Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement
Show all 9Show fewer
  • Grade 3 or higher nipple ptosis
  • Contraindicated for general anesthesia or surgery
  • Heavy current smoking history (defined as > 20 cigarettes per day)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Deborah Farr, MD, FACS contact

214-648-4133

Deborah.Farr@UTSouthwestern.edu

United States1 site, 1 recruiting

  • UT Southwestern

    Dallas, Texas, 75390

    Deborah E Farr, MD

    Recruiting

Other trials in United States

About this study

Official title: Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial

This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer.

Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.

Read the detailed description

rNSM using the multi-port robotic platform followed by standard of care open breast reconstruction has been done successfully at multiple institutions worldwide with comparable, if not superior outcomes to an open surgical approach. This study explores this procedure with the Da Vinci SP robot with pre-pectoral reconstruction with acellular dermal matrix. The patients will be evaluated per standard of care post-operative visits at 2 weeks, 1 month, and every 6 months for five years post operatively for subjective patient satisfaction and objectively for post-operative nipple sensation. The patients will be monitored longitudinally for oncologic outcomes including the presence of a new breast cancer and/or breast cancer recurrence. Patients will be monitored for any complications related to rNSM and the use of ADM in expander and implant-based breast reconstruction.

Investigational Device:

The da Vinci SP Surgical System, Model SP1098 is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories.

Indications for Use:

The da Vinci SP Surgical System, Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors. This investigational study will evaluate device usage in nipple sparing mastectomy (NSM) procedures.

Being tested
da Vinci SP Surgical System
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • da Vinci SP Surgical SystemDevice

    Also called da Vinci SP Surgical System, Model SP1098

    This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.

Study groups in NCT05245812
Study groupRoleWhat they receive
Treatment arm (SPrNSM)ExperimentalPatients will undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm)
Receives: Device: da Vinci SP Surgical System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who complete single port nipple sparing mastectomy (SPrNSM)

    The number of participants who complete single port nipple sparing mastectomy (SPrNSM) will be measured.

    Measured: Date of surgery (Day 1)

  2. Incidence of perioperative complications

    Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event. Perioperative complication rates will be compared to historical complication rates.

    Measured: 30 days following surgery

Secondary outcomes (8)

  1. Number of participants with positive margins

    The pathologist will assess margin status in patients undergoing SPrNSM

    Measured: 2 weeks following date of surgery

  2. Number of participants with new breast cancers

    The PI will assess new breast cancers.

    Measured: following date of surgery up to 5 years

  3. Number of participants with recurrent breast cancers

    The PI will assess recurrent breast cancers.

    Measured: following date of surgery up to 5 years

  4. Patient satisfaction as measured by BREAST-Q reconstruction tool

    Patient satisfaction is measured by BREAST-Q reconstruction tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. BREAST-Q reconstruction module and Breast implant illness survey for patients. Questions about self-confidence, comfort, acceptance of new appearance, feeling of implants, breast pain. The score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire .

    Measured: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

  5. Patient satisfaction as measured by BREAST-Q sensation tool

    Patient satisfaction is measured by BREAST-Q sensation tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years and it is another tool to help quantify breast sensation both pre-operatively and post-operatively. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains: i) Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains: i) Psychosocial well-being ii) Sexual well-being and iii) Physical well-being. The values range from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire.

    Measured: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

  6. Degree to which the patients maintain nipple sensation as measured by Semmes Weinstein monofilament tool at baseline

    Degree to which the patients maintain nipple sensation will be measured by Semmes Weinstein monofilament tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. Monofilament diameter and force will be measured at 9 different locations of the breast to determine the degree of sensation.

    Measured: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

  7. Incidence of short term complications

    Reconstruction outcomes is measured by short term complications (wounds, infections, seromas, and device exchange or loss) that occur post-operatively after surgery Short term complications will be described using the NCI CTACAE v. 4.03 criteria.

    Measured: Post-operatively at 30 days

  8. Incidence of long term complications

    Long term complications will be described using the NCI CTACAE v. 4.03 criteria and will refer to any medical occurrence directly attributed to the surgical procedure up to 5 years following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event.

    Measured: Following surgery up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start8 Mar 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05245812
Sponsor's protocol ID
STU-2022-0091
Status last verified
Sep 2026
First submitted
8 Feb 2022
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Farr DE, Haddock NT, Tellez J, Radi I, Alterio R, Sayers B, Zeh H 3rd. Safety and Feasibility of Single-Port Robotic-Assisted Nipple-Sparing Mastectomy. JAMA Surg. 2024 Mar 1;159(3):269-276. doi: 10.1001/jamasurg.2023.6999.

    PubMed 38231502

Questions about this trial

What is this clinical trial studying?

A study testing da Vinci SP Surgical System in people with Breast Cancer and High Risk of Breast Cancer, run by Deborah Farr, MD 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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. 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?

Contact Deborah Farr, MD, FACS (214-648-4133, Deborah.Farr@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who complete single port nipple sparing mastectomy (SPrNSM) (time frame: Date of surgery (Day 1)). The study lists 2 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 NCT05245812, 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 5 Oct 2026.

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