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Sensation DisorderNIPSENSENCT07062458

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

An observational study of Sensation Disorder, run by Candiolo Cancer Institute - IRCCS at 1 site in Italy.

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

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Sensation Disorder
What is being tested?
Nipple Sensation Assessment
How many people
90 participants
Where
1 siteItaly
Study dates
1 Jun 2025to 1 Dec 2027
Phase
Observational
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

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

Giada Pozzi, MD contact

+39 011 9933017

giada.pozzi@ircc.it

Italy1 site, 1 recruiting

  • Candiolo Cancer Institute FPO-IRCCS

    Torino, 10060

    Candiolo Cancer Institute FPO-IRCCS, +39 0119933111, social@ircc.it

    Recruiting

Other trials in Italy

About this study

Official title: 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:

Read more

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)

Read the 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.

Being tested
Nipple Sensation Assessment
Keywords
Nipple sensation, Sensory outcomes, Quality of life, Endoscopic breast surgery, Robotic breast surgery, Breast cancer surgery, Nipple-sparing mastectomy, Breast reconstruction, R-NSM, E-NSM, conventional mastectomy
Medical subject headings
Sensation Disorders

What participants receive

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

  • Nipple Sensation AssessmentDiagnostic test

    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.
Study groups in NCT07062458
Study groupRoleWhat they receive
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.
Receives: Diagnostic Test: Nipple Sensation Assessment
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
Receives: Diagnostic Test: Nipple Sensation Assessment
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.
Receives: Diagnostic Test: Nipple Sensation Assessment

What is being measured

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

  1. measurement of nipple sensation preservation

    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.

    Measured: 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 outcomes (3)

  1. surgical outcomes

    nipple-areola complex necrosis, skin flaps necrosis, infection, bleeding, seroma, wound dehiscence,

    Measured: from enrollment to 3 months

  2. anatomopathological findings

    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

    Measured: 30-60 days post-surgery

  3. PROMs

    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)

    Measured: From enrollment to 6 monts postoperatively

Timeline

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

  1. First posted14 Jul 2025
  2. Study start1 Jun 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 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
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07062458
Sponsor's protocol ID
NIPSENSE
Other IDs
00043/2025
Acronym
NIPSENSE
Status last verified
Jul 2025
First submitted
18 Jun 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Moortgat P, Anthonissen M, Van Daele U, Meirte J, Vanhullebusch T, Maertens K. Objective Assessment Techniques: Physiological Parameters in Scar Assessment. 2020 Dec 8. In: Teot L, Mustoe TA, Middelkoop E, Gauglitz GG, editors. Textbook on Scar Management: State of the Art Management and Emerging Technologies [Internet]. Cham (CH): Springer; 2020. Chapter 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK586121/

    PubMed 36351153

  • Kostidou E, Schmelz M, Hasemaki N, Kokotis P. Objective Methods for Breast Sensibility Testing. Plast Reconstr Surg. 2019 Feb;143(2):398-404. doi: 10.1097/PRS.0000000000005200.

    PubMed 30688881

  • Tevlin R, Brazio P, Tran N, Nguyen D. Immediate targeted nipple-areolar complex re-innervation: Improving outcomes in immediate autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2021 Jul;74(7):1503-1507. doi: 10.1016/j.bjps.2020.11.021. Epub 2020 Dec 3.

    PubMed 33341386

  • Prado A, Andrades P, Benitez S, Parada F. Areola-nipple perception threshold to faradic electricity: a new measure of sensibility of the breasts. Aesthetic Plast Surg. 2008 Sep;32(5):748-52. doi: 10.1007/s00266-008-9148-4. Epub 2008 Apr 29.

    PubMed 18443851

  • Weinstein S. Fifty years of somatosensory research: from the Semmes-Weinstein monofilaments to the Weinstein Enhanced Sensory Test. J Hand Ther. 1993 Jan-Mar;6(1):11-22; discussion 50.

    PubMed 8343870

  • Santanelli F, Paolini G, Bittarelli D, Nofroni I. Computer-assisted evaluation of nipple-areola complex sensibility in macromastia and following superolateral pedicle reduction mammaplasty: a statistical analysis. Plast Reconstr Surg. 2007 May;119(6):1679-1683. doi: 10.1097/01.prs.0000258828.84107.59.

    PubMed 17440341

  • van Verschuer VM, Mureau MA, Gopie JP, Vos EL, Verhoef C, Menke-Pluijmers MB, Koppert LB. Patient Satisfaction and Nipple-Areola Sensitivity After Bilateral Prophylactic Mastectomy and Immediate Implant Breast Reconstruction in a High Breast Cancer Risk Population: Nipple-Sparing Mastectomy Versus Skin-Sparing Mastectomy. Ann Plast Surg. 2016 Aug;77(2):145-52. doi: 10.1097/SAP.0000000000000366.

    PubMed 26076217

  • Kasielska-Trojan A, Szulia A, Zawadzki T, Antoszewski B. The Assessment of Nipple Areola Complex Sensation with Semmes-Weinstein Monofilaments-Normative Values and Its Covariates. Diagnostics (Basel). 2021 Nov 19;11(11):2145. doi: 10.3390/diagnostics11112145.

    PubMed 34829492

  • Jerosch-Herold C. Assessment of sensibility after nerve injury and repair: a systematic review of evidence for validity, reliability and responsiveness of tests. J Hand Surg Br. 2005 Jun;30(3):252-64. doi: 10.1016/j.jhsb.2004.12.006.

    PubMed 15862365

  • Schlenz I, Kuzbari R, Gruber H, Holle J. The sensitivity of the nipple-areola complex: an anatomic study. Plast Reconstr Surg. 2000 Mar;105(3):905-9. doi: 10.1097/00006534-200003000-00012.

    PubMed 10724249

  • Bijkerk E, Cornelissen AJM, Sommer M, Van Der Hulst RRWJ, Lataster A, Tuinder SMH. Intercostal nerve block of the anterior cutaneous branches and the sensibility of the female breast. Clin Anat. 2020 Oct;33(7):1025-1032. doi: 10.1002/ca.23532. Epub 2019 Dec 23.

    PubMed 31837172

  • Riccio CA, Zeiderman MR, Chowdhry S, Brooks RM, Kelishadi SS, Tutela JP, Choo J, Yonick DV, Wilhelmi BJ. Plastic Surgery of the Breast: Keeping the Nipple Sensitive. Eplasty. 2015 Jul 2;15:e28. eCollection 2015.

    PubMed 26171100

  • Sarhadi NS, Shaw-Dunn J, Soutar DS. Nerve supply of the breast with special reference to the nipple and areola: Sir Astley Cooper revisited. Clin Anat. 1997;10(4):283-8. doi: 10.1002/(SICI)1098-2353(1997)10:43.0.CO;2-G.

    PubMed 9213048

  • Shridharani SM, Magarakis M, Stapleton SM, Basdag B, Seal SM, Rosson GD. Breast sensation after breast reconstruction: a systematic review. J Reconstr Microsurg. 2010 Jul;26(5):303-10. doi: 10.1055/s-0030-1249313. Epub 2010 Mar 1.

    PubMed 20195965

  • Rodriguez-Unda NA, Bello RJ, Clarke-Pearson EM, Sanyal A, Cooney CM, Manahan MA, Rosson GD. Nipple-Sparing Mastectomy Improves Long-Term Nipple But Not Skin Sensation After Breast Reconstruction: Quantification of Long-Term Sensation in Nipple Sparing Versus Non-nipple Sparing Mastectomy. Ann Plast Surg. 2017 Jun;78(6):697-703. doi: 10.1097/SAP.0000000000000900.

    PubMed 27759590

Questions about this trial

What is this clinical trial studying?

An observational study of Sensation Disorder, run by Candiolo Cancer Institute - IRCCS at 1 site in Italy.

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 6 inclusion and 5 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 14 Jul 2025. 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 Italy. 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 Giada Pozzi, MD (+39 011 9933017, giada.pozzi@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). 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 NCT07062458, which also lists 32 linked publications.

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 14 Jul 2025.

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