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Procedure

Robotic Nipple-Sparing Mastectomy for Breast Cancer

N/A
Recruiting
Led By Deborah Farr, MD, FACS
Research Sponsored by Deborah Farr, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following surgery up to 5 years
Awards & highlights

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-

Who is the study for?
This trial is for individuals with breast cancer or at high risk of it, who are fit enough for surgery (good performance status) and candidates for nipple sparing mastectomy. It excludes those with severe nipple sagging, skin tumor involvement, contraindications to anesthesia/surgery, heavy smokers, NAC tumor diagnosis, inability to consent, and pregnant/nursing women.Check my eligibility
What is being tested?
The study tests the safety and feasibility of using a robotic system called da Vinci SP for performing nipple sparing mastectomies followed by immediate reconstruction. The goal is to compare this method's outcomes in terms of safety and patient satisfaction against traditional open surgeries.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include reactions to anesthesia, infection from surgery, complications from implant materials like ADM used in reconstruction (Alloderm), pain or changes in sensation around the operated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to perform daily activities without being limited by your health condition (ECOG performance status 0 or 1).
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You are not eligible if you are planning to have a certain type of breast surgery for risk reduction or treatment of breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following surgery up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and following surgery up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of perioperative complications
Number of participants who complete single port nipple sparing mastectomy (SPrNSM)
Secondary outcome measures
Degree to which the patients maintain nipple sensation as measured by Semmes Weinstein monofilament tool at baseline
Incidence of long term complications
Incidence of short term complications
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment arm (SPrNSM)Experimental Treatment1 Intervention
Patients will undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm)

Find a Location

Who is running the clinical trial?

Deborah Farr, MDLead Sponsor
Deborah Farr, MD, FACSPrincipal InvestigatorUT Southwestern Medical Center

Media Library

Robotic SP Nipple Sparing Mastectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05245812 — N/A
Breast Cancer Research Study Groups: Treatment arm (SPrNSM)
Breast Cancer Clinical Trial 2023: Robotic SP Nipple Sparing Mastectomy Highlights & Side Effects. Trial Name: NCT05245812 — N/A
Robotic SP Nipple Sparing Mastectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245812 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~43 spots leftby Feb 2026