Breast CancerNEARSENSENCT07902661
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
A study testing Nerve anastomosis in people with Breast Cancer, run by Gangnam Severance Hospital.
Trial summary
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nerve anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2026to 1 Feb 2033
- Phase
- Interventional
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 years or older with histopathologically confirmed invasive breast cancer.
- Patients scheduled to undergo nipple-sparing mastectomy and immediate implant-based breast reconstruction in the subpectoral space for breast cancer.
- Regardless of the history of pre- or post-operative chemotherapy, or the planned receipt of post-operative radiation therapy.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Patients who have provided written informed consent prior to the initiation of the study.
Who cannot join
- Patients with a prior history of breast surgery (e.g., benign breast tumor excision, breast cancer surgery, breast augmentation, breast reduction, etc.).
- Patients who cannot undergo nipple-sparing mastectomy.
- Patients with bilateral breast cancer.
- Patients with a history of cancers other than breast cancer diagnosed within the past 5 years (excluding adequately treated non-melanoma skin cancer and thyroid cancer).
- Patients with pathologically or radiologically confirmed systemic metastasis.
- Patients with inflammatory breast cancer, neuroendocrine tumor, or malignant phyllodes tumor.
- Pregnant or breastfeeding patients.
- Patients who have difficulty understanding the informed consent form.
About this study
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction.
Breast sensation, including sensation of the nipple-areolar complex, may be diminished or lost following mastectomy because of injury to the sensory nerves supplying the breast skin and nipple-areolar complex. Sensory nerve coaptation may improve sensory recovery after surgery. This study will compare sensory recovery between patients who undergo sensory nerve coaptation and those who do not, with the aim of evaluating whether sensory nerve coaptation improves postoperative breast sensation.
Read the detailed description
Background and Scientific Rationale Breast Cancer and Nipple-Sparing Mastectomy Breast cancer is the most commonly diagnosed cancer among women in Korea, and its incidence has continued to increase. Compared with Western countries, breast cancer in Korea occurs relatively frequently in women in their 40s and 50s. Advances in breast cancer surgery and reconstruction have increasingly focused on improving cosmetic outcomes, patient satisfaction, and quality of life.
Nipple-sparing mastectomy (NSM), which preserves the nipple-areolar complex, is increasingly performed in appropriately selected patients undergoing mastectomy with immediate breast reconstruction. Previous studies have reported comparable survival outcomes and complication profiles between NSM and conventional mastectomy or skin-sparing mastectomy in selected patients.
Loss of Breast and Nipple-Areolar Sensation Despite advances in mastectomy techniques, breast reconstruction, implants, and acellular dermal matrices, postoperative sensory loss remains an important unresolved concern. Sensory impairment may occur because mastectomy can injure the medial and lateral intercostal nerves that provide sensation to the breast skin. Sensation in the nipple-areolar complex is also supplied by branches of the intercostal nerves, particularly the third through fifth intercostal nerves.
Previous studies have suggested that sensory nerve reconstruction, including coaptation of transected lateral intercostal nerves to the nipple-areolar complex using nerve allografts in selected procedures, may improve postoperative sensory recovery. However, prospective evaluation of sensory nerve coaptation during nipple-sparing mastectomy with immediate breast reconstruction remains limited.
Rationale for the Study Sensory nerve coaptation during nipple-sparing mastectomy with immediate breast reconstruction may improve postoperative sensory recovery. Improved sensation may contribute to greater patient satisfaction and quality of life. Given the proportion of breast cancer patients undergoing mastectomy with reconstruction at the participating institution, this approach may have potential clinical relevance for a substantial number of patients.
However, prospective evidence demonstrating the benefit of sensory nerve coaptation in this specific surgical setting is lacking. A randomized clinical trial is therefore needed to evaluate its effect on postoperative sensory recovery.
Study Objective The primary objective of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction.
Potential Benefits and Risks Patients assigned to the sensory nerve coaptation group may experience improved postoperative sensory recovery. If the intervention is shown to be beneficial, the findings may help inform future surgical practice and potentially improve patient satisfaction and quality of life after breast cancer surgery.
Potential risks associated with sensory nerve coaptation include additional surgical complications and abnormal sensations. Previous retrospective studies have reported that complications and abnormal sensory symptoms associated with these procedures were uncommon. However, such risks cannot be excluded.
The study will compare sensory recovery between patients undergoing sensory nerve coaptation and those not undergoing the procedure to evaluate its potential benefits in the setting of nipple-sparing mastectomy with immediate breast reconstruction.
- Conditions
- Breast Cancer
- Being tested
- Nerve anastomosis
- Keywords
- Sensory Nerve Coaptation, Nipple-Sparing Mastectomy, Immediate Breast Reconstruction, Breast Sensation, Sensory Recovery, Randomized Controlled Trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve anastomosisProcedure or surgery
For the Control Group (Cohort 1):
Patients will undergo a nipple-sparing mastectomy and immediate implant-based breast reconstruction using the same ADM-wrapped silicone implant technique without nerve anastomosis.
For the Nerve Anastomosis Group (Cohort 2):
Patients will undergo a nipple-sparing mastectomy followed by immediate implant-based breast reconstruction. A breast pocket is created beneath the mastectomy flap, and the silicone implant is completely wrapped in an Acellular Dermal Matrix (ADM) to prevent capsular contracture before insertion into the pocket.
During the mastectomy, the 3rd to 5th intercostal nerves located on the lateral side of the thoracic cage and the subareolar nerves are meticulously preserved to secure adequate length. Direct end-to-end nerve anastomosis is performed when possible. In cases where a nerve gap prevents direct tension-free closure, an acellular allograft nerve (MegaNerve prime®) is used to bridge the gap via end-to-end anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants will undergo nipple-sparing mastectomy with immediate breast reconstruction without sensory nerve coaptation. |
| Sensory Nerve Coaptation Group | Experimental | Participants will undergo nipple-sparing mastectomy with immediate breast reconstruction and sensory nerve coaptation. Receives: Procedure: Nerve anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nipple-Areolar Complex (NAC) Tactile Sensitivity Score
Measured using standardized tactile tests (e.g., Semmes-Weinstein monofilaments).
Measured: Post-operative Month [예: 6,12,18,24,30,36 months]
Change in Breast Skin Tactile Sensitivity Score
Measured using standardized tactile tests across designated breast skin areas.
Measured: Post-operative Month [예: 6,12,18,24,30,36 months]
Secondary outcomes (5)
Change in Nipple-Areolar Complex (NAC) Thermal Sensitivity Score
Measured using thermal sensitivity testing.
Measured: Post-operative Month [예: 6,12,18,24,30,36 months]
Change in Breast Skin Thermal Sensitivity Score
Measured using thermal sensitivity testing.
Measured: Post-operative Month [예: 6,12,18,24,30,36 months]
Patient-Reported Outcomes Using Breast-Q Reconstruction Module and 4 Subjective Skin Sensitivity Questions
Assessed via the Breast-Q questionnaire and an additional 4-item subjective questionnaire regarding skin sensation.
Measured: Post-operative Month [예: 6,12,18,24,30,36 months]
Sensory Recovery Comparison According to the Number of Anastomosed Nerve Branches (1, 2, or 3)
Comparison of nerve recovery outcomes based on the number of successfully anastomosed nerve branches.
Measured: Post-operative Month [예: 6,12,18,24,30,36 months]
Post-operative Complications
Incidence and severity of surgical complications.
Measured: Post-operative Month [예: 36 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start27 Oct 2026 (estimated)
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Gwe Ahn, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902661
- Sponsor's protocol ID
- 3-2025-0201
- Acronym
- NEARSENSE
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT07902661
- Acronym / sponsor ID
- NEARSENSE / 3-2025-0201
- Conditions
- Breast Cancer
- Keywords
- Sensory Nerve Coaptation, Nipple-Sparing Mastectomy, Immediate Breast Reconstruction, Breast Sensation, Sensory Recovery, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 27 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction.
Breast sensation, including sensation of the nipple-areolar complex, may be diminished or lost following mastectomy because of injury to the sensory nerves supplying the breast skin and nipple-areolar complex. Sensory nerve coaptation may improve sensory recovery after surgery. This study will compare sensory recovery between patients who undergo sensory nerve coaptation and those who do not, with the aim of evaluating whether sensory nerve coaptation improves postoperative breast sensation.
Detailed description
Background and Scientific Rationale Breast Cancer and Nipple-Sparing Mastectomy Breast cancer is the most commonly diagnosed cancer among women in Korea, and its incidence has continued to increase. Compared with Western countries, breast cancer in Korea occurs relatively frequently in women in their 40s and 50s. Advances in breast cancer surgery and reconstruction have increasingly focused on improving cosmetic outcomes, patient satisfaction, and quality of life.
Nipple-sparing mastectomy (NSM), which preserves the nipple-areolar complex, is increasingly performed in appropriately selected patients undergoing mastectomy with immediate breast reconstruction. Previous studies have reported comparable survival outcomes and complication profiles between NSM and conventional mastectomy or skin-sparing mastectomy in selected patients.
Loss of Breast and Nipple-Areolar Sensation Despite advances in mastectomy techniques, breast reconstruction, implants, and acellular dermal matrices, postoperative sensory loss remains an important unresolved concern. Sensory impairment may occur because mastectomy can injure the medial and lateral intercostal nerves that provide sensation to the breast skin. Sensation in the nipple-areolar complex is also supplied by branches of the intercostal nerves, particularly the third through fifth intercostal nerves.
Previous studies have suggested that sensory nerve reconstruction, including coaptation of transected lateral intercostal nerves to the nipple-areolar complex using nerve allografts in selected procedures, may improve postoperative sensory recovery. However, prospective evaluation of sensory nerve coaptation during nipple-sparing mastectomy with immediate breast reconstruction remains limited.
Rationale for the Study Sensory nerve coaptation during nipple-sparing mastectomy with immediate breast reconstruction may improve postoperative sensory recovery. Improved sensation may contribute to greater patient satisfaction and quality of life. Given the proportion of breast cancer patients undergoing mastectomy with reconstruction at the participating institution, this approach may have potential clinical relevance for a substantial number of patients.
However, prospective evidence demonstrating the benefit of sensory nerve coaptation in this specific surgical setting is lacking. A randomized clinical trial is therefore needed to evaluate its effect on postoperative sensory recovery.
Study Objective The primary objective of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction.
Potential Benefits and Risks Patients assigned to the sensory nerve coaptation group may experience improved postoperative sensory recovery. If the intervention is shown to be beneficial, the findings may help inform future surgical practice and potentially improve patient satisfaction and quality of life after breast cancer surgery.
Potential risks associated with sensory nerve coaptation include additional surgical complications and abnormal sensations. Previous retrospective studies have reported that complications and abnormal sensory symptoms associated with these procedures were uncommon. However, such risks cannot be excluded.
The study will compare sensory recovery between patients undergoing sensory nerve coaptation and those not undergoing the procedure to evaluate its potential benefits in the setting of nipple-sparing mastectomy with immediate breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will undergo nipple-sparing mastectomy with immediate breast reconstruction without sensory nerve coaptation. |
| Sensory Nerve Coaptation Group | Experimental | Procedure: Nerve anastomosisParticipants will undergo nipple-sparing mastectomy with immediate breast reconstruction and sensory nerve coaptation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20 years or older with histopathologically confirmed invasive breast cancer.
- Patients scheduled to undergo nipple-sparing mastectomy and immediate implant-based breast reconstruction in the subpectoral space for breast cancer.
- Regardless of the history of pre- or post-operative chemotherapy, or the planned receipt of post-operative radiation therapy.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Patients who have provided written informed consent prior to the initiation of the study.
Key exclusion criteria (8 listed)
- Patients with a prior history of breast surgery (e.g., benign breast tumor excision, breast cancer surgery, breast augmentation, breast reduction, etc.).
- Patients who cannot undergo nipple-sparing mastectomy.
- Patients with bilateral breast cancer.
- Patients with a history of cancers other than breast cancer diagnosed within the past 5 years (excluding adequately treated non-melanoma skin cancer and thyroid cancer).
- Patients with pathologically or radiologically confirmed systemic metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve anastomosisFor the Control Group (Cohort 1): Patients will undergo a nipple-sparing mastectomy and immediate implant-based breast reconstruction using the same ADM-wrapped silicone implant technique without nerve anastomosis. For the Nerve Anastomosis Group (Cohort 2): Patients will undergo a nipple-sparing mastectomy followed by immediate implant-based breast reconstruction. A breast pocket is created beneath the mastectomy flap, and the silicone implant is completely wrapped in an Acellular Dermal Matrix (ADM) to prevent capsular contracture before insertion into the pocket. During the mastectomy, the 3rd to 5th intercostal nerves located on the lateral side of the thoracic cage and the subareolar nerves are meticulously preserved to secure adequate length. Direct end-to-end nerve anastomosis is performed when possible. In cases where a nerve gap prevents direct tension-free closure, an acellular allograft nerve (MegaNerve prime®) is used to bridge the gap via end-to-end anastomosis. | Procedure or surgery | Sensory Nerve Coaptation Group |
Primary outcome
Change in Nipple-Areolar Complex (NAC) Tactile Sensitivity Score
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Measured using standardized tactile tests (e.g., Semmes-Weinstein monofilaments).
Change in Breast Skin Tactile Sensitivity Score
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Measured using standardized tactile tests across designated breast skin areas.
5 secondary outcomes
Change in Nipple-Areolar Complex (NAC) Thermal Sensitivity Score
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Change in Breast Skin Thermal Sensitivity Score
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Patient-Reported Outcomes Using Breast-Q Reconstruction Module and 4 Subjective Skin Sensitivity Questions
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Sensory Recovery Comparison According to the Number of Anastomosed Nerve Branches (1, 2, or 3)
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Post-operative Complications
Time frame: Post-operative Month [예: 36 months]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve anastomosis in people with Breast Cancer, run by Gangnam Severance Hospital.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nipple-Areolar Complex (NAC) Tactile Sensitivity Score (time frame: Post-operative Month [예: 6,12,18,24,30,36 months]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.