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

NCT ID: NCT04537312

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2026-10-31

Brief Summary

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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

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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

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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 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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Supportive care (RNSM, surveys)

RNMS Surveys

Group Type EXPERIMENTAL

Robot-assisted Nipple Sparing Mastectomy

Intervention Type PROCEDURE

Under RNSM

Survey Administration

Intervention Type OTHER

ancillary correlative

RNSM

Intervention Type DEVICE

Robot-assisted Nipple Sparing Mastectomy

Interventions

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Robot-assisted Nipple Sparing Mastectomy

Under RNSM

Intervention Type PROCEDURE

Survey Administration

ancillary correlative

Intervention Type OTHER

RNSM

Robot-assisted Nipple Sparing Mastectomy

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Sara Myers

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Carson, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34782341 (View on PubMed)

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2020-05349

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-19199

Identifier Type: -

Identifier Source: org_study_id