Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)

NCT04537312 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: OSU-19199NCI-2020-05349
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anatomic Stage IIA Breast Cancer AJCC v8; 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 IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Ductal Breast Carcinoma In Situ; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prophylactic Mastectomy

Outcome Measures

Primary Outcomes (7)

• Feasibility of removal of breast gland en bloc through RNSM

  Measure number of patients who had breast removed en bloc through RNSM incision.

  Up to 1 year

• Complication rate of patients with bleeding requiring re-operation

  Number of patients with bleeding requiring re-operation after RNSM.

  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.

  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.

  Up to 1 year

• Perioperative Outcomes investigating the total duration of surgical time

  Investigate the total duration of the operation (surgical time data),

  Up to 1 year

• Perioperative Outcomes investigating length of surgery time

  Investigate the total duration of the operation (surgical time data) of each patient

  Up to 1 year

• Perioperative Outcomes investigating the length of hospitalization

  Investigate the length of hospitalization for each patient

  Up to 1 year

Secondary Outcomes (4)

• Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey

  Up to 1 year

• Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire

  Up to 1 year

• Patient Reported Outcomes

  Up to 1 year

• Patient Reported Outcomes

  Up to 1 year

Study Arms (1)

Supportive care (RNSM, surveys)

EXPERIMENTAL

RNMS Surveys

Procedure: Robot-assisted Nipple Sparing Mastectomy; Other: Survey Administration; Device: RNSM

Interventions

Survey Administration OTHER

ancillary correlative

Supportive care (RNSM, surveys)

Robot-assisted Nipple Sparing Mastectomy PROCEDURE

Under RNSM

Supportive care (RNSM, surveys)

RNSM DEVICE

Robot-assisted Nipple Sparing Mastectomy

Supportive care (RNSM, surveys)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 34782341 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• William Carson, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 3, 2020
• Study Start: November 17, 2020
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)