A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques (NIPSENSE)

July 10, 2025 updated by: Giada Pozzi, Candiolo Cancer Institute - IRCCS

NIPSENSE - A Comparative Study of Nipple and Skin Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, and Robotic Techniques

The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM). The study will compare three types of NSM: conventional, endoscopic, and robotic.

The main question it aims to answer is:

How much nipple sensation do participants keep after each type of surgery?

Researchers will also look at surgery-related complications, patient-reported outcomes like body image and quality of life, and tissue analysis to see if there is a link between nerve structures and sensation.

Participants will:

Have NSM using one of the three surgical approaches

Receive breast reconstruction with an implant during the same surgery

Complete nipple sensation tests before and at 1, 3, and 6 months after surgery

Answer surveys about their quality of life and body image

Provide surgical tissue for analysis (as part of the planned procedure)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The NIPSENSE study is a prospective, single-center study comparing how well nipple sensation is preserved after three types of nipple-sparing mastectomy (NSM): Conventional NSM (C-NSM), Endoscopic NSM (E-NSM), and Robotic NSM (R-NSM). The goal is to better understand the sensory and quality-of-life outcomes associated with each technique.

A total of 90 female participants (30 in each group) will be recruited. All will undergo NSM with direct-to-implant reconstruction. Participants will be assessed for nipple and skin sensation before surgery, and again at 1, 3, and 6 months after surgery, using a standard medical tool called the Semmes-Weinstein esthesiometer.

The study will also evaluate:

Surgical complications (e.g., infection, bleeding, skin necrosis)

Patient-reported outcomes using validated tools like the Hopwood Body Image Scale and EORTC questionnaires

Tissue analysis to explore whether preserved nerve structures are related to the level of sensation after surgery

This study will provide important data about how surgical methods impact physical and emotional outcomes for people undergoing mastectomy. The findings may help improve patient care and inform future decisions about surgical approaches to breast cancer treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Torino, Italy, 10060
        • Recruiting
        • Candiolo Cancer Institute FPO-IRCCS
        • Contact:
          • Candiolo Cancer Institute FPO-IRCCS
          • Phone Number: +39 0119933111
          • Email: social@ircc.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of female patients aged 18 years or older, eligible for mastectomy for early-stage breast cancer or high-risk conditions, who meet the study eligibility criteria. A total of 90 patients will be recruited at Candiolo Cancer Institute in Torino (Italy).

Description

Inclusion Criteria:

  • Female patients aged ≥18 years.
  • Diagnosed with early-stage breast cancer or deemed at high risk for breast cancer (eg. BRCA1-2 mutations).
  • Candidates for Nipple-Sparing Mastectomy (NSM).
  • Able to provide informed consent.
  • No contraindications for surgery based on physical examination and preoperative assessment.
  • Signed the consent forms and willing to participate in all scheduled follow-up assessments.

Exclusion Criteria:

  • Previous breast surgery.
  • History of radiation therapy to the chest/breast area.
  • Active or non-controlled diabetes mellitus.
  • Neuropathies causing potentially altered skin sensation.
  • Nipple involvement by cancer, clinical or reported intra-operatively via frozen section analysis (the procedure will be converted to SSM).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Conventional Nipple-Sparing Mastectomy (C-NSM)
Participants in this group will undergo a standard open nipple-sparing mastectomy using traditional surgical instruments. The procedure is performed through a visible incision on the breast, while preserving the nipple and surrounding skin. An implant is placed for immediate reconstruction.
Diagnostic test: Nipple Sensation Assessment

the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded. This assessment will be conducted at four different times:

  • Before surgery, to assess baseline sensation.
  • 1 month after surgery.
  • 3 months after surgery.
  • 6 months after surgery.
Endoscopic Nipple-Sparing Mastectomy (E-NSM)
This group will receive a minimally invasive nipple-sparing mastectomy using an endoscopic technique. The breast tissue is removed through a small incision in the armpit using a camera and specialized instruments. An implant is placed during the same surgery
Diagnostic test: Nipple Sensation Assessment

the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded. This assessment will be conducted at four different times:

  • Before surgery, to assess baseline sensation.
  • 1 month after surgery.
  • 3 months after surgery.
  • 6 months after surgery.
Robotic Nipple-Sparing Mastectomy (R-NSM)
Participants in this group will undergo a robotic-assisted nipple-sparing mastectomy. The surgery is performed using a robotic surgical system through a small armpit incision, offering enhanced precision and visualization. Immediate implant reconstruction is also performed.
Diagnostic test: Nipple Sensation Assessment

the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded. This assessment will be conducted at four different times:

  • Before surgery, to assess baseline sensation.
  • 1 month after surgery.
  • 3 months after surgery.
  • 6 months after surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measurement of nipple sensation preservation
Time Frame: This assessment will be conducted at four different times: • Before surgery, to assess baseline sensation. • 1 month after surgery. • 3 months after surgery. • 6 months after surgery.
The primary objective, the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded.
This assessment will be conducted at four different times: • Before surgery, to assess baseline sensation. • 1 month after surgery. • 3 months after surgery. • 6 months after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
surgical outcomes
Time Frame: from enrollment to 3 months
nipple-areola complex necrosis, skin flaps necrosis, infection, bleeding, seroma, wound dehiscence,
from enrollment to 3 months
anatomopathological findings
Time Frame: 30-60 days post-surgery
the presence or absence of sensory cutaneous receptors in the subcutaneous layer of the specimen and their possible correlation to the degree of cutaneous sensation
30-60 days post-surgery
PROMs
Time Frame: From enrollment to 6 monts postoperatively
Questionnaires will be administered to the patients to assess patient-reported outcomes: Hopwood Body Image Scale (score 0 to 30, higher scores meaning a worst outcome), and EORTC - European Organisation for Research and Treatment of Cancer, BR-23 questionnaire (no total score, each question compared individually between groups)
From enrollment to 6 monts postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Candiolo Cancer Institute - IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giada Pozzi, MD, Candiolo Cancer Institute FPO-IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIPSENSE
  • 00043/2025 (Registry Identifier: Comitato Etico Città della Salute e della Scienza di Torino)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request, following publication of the primary results. Shared data may include demographic details, surgical outcomes, complications, and patient-reported outcomes. Requests will be reviewed by the study team to ensure appropriate use and compliance with ethical standards. Data sharing will be subject to a data use agreement.

IPD Sharing Time Frame

IPD Sharing Time Frame: from 6 months to 24 months after end of recruitment

IPD Sharing Access Criteria

Institutions involved in breast cancer research will be able to request access by directly contacting the PI and coordinating center of the study

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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