Breast ReconstructionNCT07767838
Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.
A study testing Nipple neurotization in people with Breast Reconstruction, run by Hospital Angeles del Pedregal at 1 site in Mexico.
Trial summary
A prospective study was conducted including patients undergoing nipple-sparing mastectomy with neurotization during expander-to-implant exchange between 2021 and 2025. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Nipple neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adult female patients (≥18 years of age).
- Patients who underwent nipple-sparing mastectomy (NSM) with immediate tissue-expander placement.
- Patients undergoing nipple neurotization at the time of expander-to-implant exchange.
- Patients with a clinically viable nipple-areola complex (NAC) at the time of neurotization.
- Patients who underwent standardized sensory assessment of the breast/NAC preoperatively and at least one postoperative time point.
- Patients who provided informed consent for participation and postoperative sensory assessment.
Who cannot join
- Patients younger than 18 years of age.
- Male patients.
- Patients who underwent a mastectomy other than nipple-sparing mastectomy.
- Patients who underwent nipple neurotization at a time other than the expander-to-implant exchange.
- Patients unable to undergo standardized sensory testing or unable to reliably report sensory perception.
- Patients without adequate postoperative follow-up to perform the required sensory assessments.
- Patients who declined participation or withdrew consent.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective study was conducted including patients undergoing nipple-sparing mastectomy with neurotization during expander-to-implant exchange between 2021 and 2025.
Read the detailed description
The investigators conducted a prospective study including consecutive patients undergoing nipple-sparing mastectomy (NSM) with nipple neurotization at the time of expander-to-implant exchange between 2021 and 2025.
- Conditions
- Breast Reconstruction
- Being tested
- Nipple neurotization
- Keywords
- Breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple neurotizationProcedure or surgery
Nipple neurotization
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Not described Receives: Procedure: Nipple neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory evaluation was performed in each zone using the British Medical Research Council (BMRC) scale
Sensory recovery will be assessed using the British Medical Research Council Sensory Scale, which grades sensory function from S0 to S4. S0 represents complete absence of sensation, while S4 represents normal sensation. The scale includes intermediate grades (S1, S2, S2+, S3, and S3+) reflecting progressive recovery of pain, tactile sensation, and two-point discrimination. The minimum value is S0 and the maximum value is S4; higher scores indicate better sensory recovery.
Measured: 1 year
Sensory evaluation was performed in each zone using the Semmes-Weinstein monofilament test.
Sensory function will be assessed using Semmes-Weinstein monofilament testing with the Baseline Tactile Monofilament Test Kit, consisting of monofilaments calibrated to apply forces of 0.07 g, 0.4 g, 2.0 g, 4.0 g, and 300 g. The lowest force detected by the participant will be recorded as the sensory threshold. A lower detection threshold indicates better sensory function, with 0.07 g representing the best possible result and failure to detect the 300 g monofilament representing the worst possible result.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Jan 2021
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Angeles del Pedregal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Eduardo Telich Tarriba, Hospital Angeles del Pedregal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767838
- Sponsor's protocol ID
- PI-20-01
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT07767838
- Acronym / sponsor ID
- PI-20-01
- Conditions
- Breast Reconstruction
- Keywords
- Breast reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital Angeles del PedregalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 17 Aug 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.
A prospective study was conducted including patients undergoing nipple-sparing mastectomy with neurotization during expander-to-implant exchange between 2021 and 2025.
Detailed description
The investigators conducted a prospective study including consecutive patients undergoing nipple-sparing mastectomy (NSM) with nipple neurotization at the time of expander-to-implant exchange between 2021 and 2025.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Nipple neurotization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult female patients (≥18 years of age).
- Patients who underwent nipple-sparing mastectomy (NSM) with immediate tissue-expander placement.
- Patients undergoing nipple neurotization at the time of expander-to-implant exchange.
- Patients with a clinically viable nipple-areola complex (NAC) at the time of neurotization.
- Patients who underwent standardized sensory assessment of the breast/NAC preoperatively and at least one postoperative time point.
Key exclusion criteria (7 listed)
- Patients younger than 18 years of age.
- Male patients.
- Patients who underwent a mastectomy other than nipple-sparing mastectomy.
- Patients who underwent nipple neurotization at a time other than the expander-to-implant exchange.
- Patients unable to undergo standardized sensory testing or unable to reliably report sensory perception.
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 |
|---|---|---|
| Nipple neurotizationNipple neurotization | Procedure or surgery | Surgery |
Primary outcome
Sensory evaluation was performed in each zone using the British Medical Research Council (BMRC) scale
Time frame: 1 year
Sensory recovery will be assessed using the British Medical Research Council Sensory Scale, which grades sensory function from S0 to S4. S0 represents complete absence of sensation, while S4 represents normal sensation. The scale includes intermediate grades (S1, S2, S2+, S3, and S3+) reflecting progressive recovery of pain, tactile sensation, and two-point discrimination. The minimum value is S0 and the maximum value is S4; higher scores indicate better sensory recovery.
Sensory evaluation was performed in each zone using the Semmes-Weinstein monofilament test.
Time frame: 1 year
Sensory function will be assessed using Semmes-Weinstein monofilament testing with the Baseline Tactile Monofilament Test Kit, consisting of monofilaments calibrated to apply forces of 0.07 g, 0.4 g, 2.0 g, 4.0 g, and 300 g. The lowest force detected by the participant will be recorded as the sensory threshold. A lower detection threshold indicates better sensory function, with 0.07 g representing the best possible result and failure to detect the 300 g monofilament representing the worst possible result.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nipple neurotization in people with Breast Reconstruction, run by Hospital Angeles del Pedregal at 1 site in Mexico.
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 7 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: finished, as of the sponsor's last update on 17 Aug 2026. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensory evaluation was performed in each zone using the British Medical Research Council (BMRC) scale (time frame: 1 year). 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 17 Aug 2026.