Breast Reconstruction Following MastectomyPhase 4NCT07819357
Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
A Phase 4 study testing Allogeneic Nerve Grafting in people with Breast Reconstruction Following Mastectomy, run by Endeavor Health at 3 sites in United States.
Trial summary
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with implant-based breast reconstruction. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Breast Reconstruction Following Mastectomy
- What is being tested?
- Allogeneic Nerve Grafting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2026to Dec 2030
- Phase
- Phase 4
- 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 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects greater or equal to 22 years of age.
- Subject is considered a candidate for nipple sparing mastectomy by the breast and plastic surgeon
- First-time breast reconstruction post-mastectomy for target breasts.
- Subject is planning to undergo bilateral nipple-sparing mastectomy with immediate, implant-based, subpectoral or prepectoral breast reconstruction.
- Mastectomy performed to address ductal carcinoma-in-situ (DCIS) or for cancer prophylaxis.
- An informed consent form is signed by subject
- Subject is capable of following protocol procedures and complying with follow-up visit requirements.
Who cannot join
- Subject has undergone prior radiation therapy to the reconstruction site or chest wall.
- Subject has a BMI > 35.
- Subject has a known diagnosis of diabetes with a HbA1c > 7.0mmol/L within 30 days of the mastectomy
- Subject is a tobacco/nicotine user within 30 days prior to Index Surgery.
- Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction.
- Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
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- Subject is currently participating or planning to participate in another investigational drug, biologic, or medical device study that may interfere with compliance of this study requirements or may confound this study data/outcomes.
- Subject is pregnant or lactating at the time of the mastectomy.
- If the patient has a diagnosis of DCIS, there no radiographic evidence of DCIS within 1 cm of the skin or nipple or foci suspicious for microinvasion.
- Patients with a diagnosis of grade III DCIS.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Evanston Hospital
Evanston, Illinois, 60201
Endeavor Health, 847-504-2300, mark.sisco@endeavorhealth.org
Mark Sisco, MD, FACS
Highland Park Hospital
Highland Park, Illinois, 60035
Endeavor Health, 847-504-2300, mark.sisco@endeavorhealth.org
Mark Sisco, MD, FACS
501 Skokie Blvd Ste 250
Northbrook, Illinois, 60062
Endeavor Health, Medical Group, 847-504-2300, mark.sisco@endeavorhealth.org
Mark Sisco, MD, FACS
About this study
Official title: A Randomized, Blinded, Within-Subject Trial of Allogeneic Nerve Grafting After Bilateral Nipple-Sparing Mastectomy With Implant-Based Reconstruction
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with implant-based breast reconstruction. The main questions it aims to answer are:
- Does nerve grafting improve objective breast sensation compared with reconstruction without nerve grafting?
- Does nerve grafting improve patient-reported breast sensation?
Read more
Researchers will compare the breast that receives the nerve graft with the breast that does not receive a nerve graft to determine whether nerve grafting improves sensory recovery.
Participants will:
- Undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction as planned standard care.
- Receive an allogeneic nerve graft (Avance Nerve Scaffold) on one breast, with the side receiving the graft determined randomly.
- Have breast sensation measured using a light-touch test before surgery and at approximately 6, 12, and 24 months after surgery.
- Complete questionnaires about breast sensation at the same time points.
- Being tested
- Allogeneic Nerve Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Nerve GraftingBiological
A processed allogeneic nerve graft (Avance Nerve Scaffold) will be used to reconstruct the sensory nerve pathway during bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The breast receiving the nerve graft will be randomly assigned for each participant. The graft will be connected proximally to an identified intercostal nerve and, when an appropriate distal nerve target is identified, connected to the nerve supplying the nipple-areolar complex. When no distal nerve target is identified, the distal graft will be secured to the dermis beneath the nipple. The contralateral breast will undergo the planned implant-based reconstruction without nerve grafting and will serve as the within-subject control.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Nerve Grafting | Experimental | Participants will undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The side receiving nerve grafting will be randomly assigned for each participant. The contralateral breast will undergo standard reconstruction without nerve grafting and will serve as the within-subject control. Participants and study personnel performing sensory assessments will be blinded to treatment allocation. Receives: Biological: Allogeneic Nerve Grafting |
| No Nerve Grafting | No intervention | Participants will undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The side receiving nerve grafting will be randomly assigned for each participant. The contralateral breast will undergo standard reconstruction without nerve grafting and will serve as the within-subject control. Participants and study personnel performing sensory assessments will be blinded to treatment allocation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Sensation Measured by Semmes-Weinstein Monofilament Testing
Breast sensation will be objectively assessed using Semmes-Weinstein monofilament testing on the breast receiving the nerve graft and the contralateral non-grafted breast. Sensory measurements will be compared between the grafted and non-grafted breasts to evaluate the effect of allogeneic nerve grafting on sensory recovery.
Measured: Baseline, 6 months, 12 months, and 24 months after surgery
Secondary outcomes (1)
Patient-Reported Breast Sensation
Patient-reported breast sensation will be assessed using a study-specific questionnaire incorporating questions from the BREAST-Q Reconstruction Module. Each sensation item is scored on a 5-point Likert-type scale ranging from 1 (no feeling) to 5 (complete feeling), with higher scores indicating better breast sensation. Scores will be compared between the grafted and non-grafted breasts to evaluate whether allogeneic nerve grafting improves patients' perception of breast sensation.
Measured: Baseline, 6 months, 12 months, and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction Following MastectomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All participants will receive the same intervention, with the side receiving the nerve graft randomly assigned within each participant. The contralateral breast will serve as the control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Sisco, Endeavor Health
- Investigators
- Mark Sisco, MD, FACS, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819357
- Sponsor's protocol ID
- IRB2026-0157
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Within-Subject Trial of Allogeneic Nerve Grafting After Bilateral Nipple-Sparing Mastectomy With Implant-Based Reconstruction
- ClinicalTrials.gov ID
- NCT07819357
- Acronym / sponsor ID
- IRB2026-0157
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 14 Sep 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 goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with implant-based breast reconstruction. The main questions it aims to answer are:
- Does nerve grafting improve objective breast sensation compared with reconstruction without nerve grafting?
- Does nerve grafting improve patient-reported breast sensation?
Researchers will compare the breast that receives the nerve graft with the breast that does not receive a nerve graft to determine whether nerve grafting improves sensory recovery.
Participants will:
- Undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction as planned standard care.
- Receive an allogeneic nerve graft (Avance Nerve Scaffold) on one breast, with the side receiving the graft determined randomly.
- Have breast sensation measured using a light-touch test before surgery and at approximately 6, 12, and 24 months after surgery.
- Complete questionnaires about breast sensation at the same time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive the same intervention, with the side receiving the nerve graft randomly assigned within each participant. The contralateral breast will serve as the control.
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Nerve Grafting | Experimental | Biological: Allogeneic Nerve GraftingParticipants will undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The side receiving nerve grafting will be randomly assigned for each participant. The contralateral breast will undergo standard reconstruction without nerve grafting and will serve as the within-subject control. Participants and study personnel performing sensory assessments will be blinded to treatment allocation. |
| No Nerve Grafting | No intervention | –Participants will undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The side receiving nerve grafting will be randomly assigned for each participant. The contralateral breast will undergo standard reconstruction without nerve grafting and will serve as the within-subject control. Participants and study personnel performing sensory assessments will be blinded to treatment allocation. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female subjects greater or equal to 22 years of age.
- Subject is considered a candidate for nipple sparing mastectomy by the breast and plastic surgeon
- First-time breast reconstruction post-mastectomy for target breasts.
- Subject is planning to undergo bilateral nipple-sparing mastectomy with immediate, implant-based, subpectoral or prepectoral breast reconstruction.
- Mastectomy performed to address ductal carcinoma-in-situ (DCIS) or for cancer prophylaxis.
Key exclusion criteria (10 listed)
- Subject has undergone prior radiation therapy to the reconstruction site or chest wall.
- Subject has a BMI > 35.
- Subject has a known diagnosis of diabetes with a HbA1c > 7.0mmol/L within 30 days of the mastectomy
- Subject is a tobacco/nicotine user within 30 days prior to Index Surgery.
- Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction.
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 |
|---|---|---|
| Allogeneic Nerve GraftingA processed allogeneic nerve graft (Avance Nerve Scaffold) will be used to reconstruct the sensory nerve pathway during bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The breast receiving the nerve graft will be randomly assigned for each participant. The graft will be connected proximally to an identified intercostal nerve and, when an appropriate distal nerve target is identified, connected to the nerve supplying the nipple-areolar complex. When no distal nerve target is identified, the distal graft will be secured to the dermis beneath the nipple. The contralateral breast will undergo the planned implant-based reconstruction without nerve grafting and will serve as the within-subject control. | Biological | Allogeneic Nerve Grafting |
Primary outcome
Breast Sensation Measured by Semmes-Weinstein Monofilament Testing
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
Breast sensation will be objectively assessed using Semmes-Weinstein monofilament testing on the breast receiving the nerve graft and the contralateral non-grafted breast. Sensory measurements will be compared between the grafted and non-grafted breasts to evaluate the effect of allogeneic nerve grafting on sensory recovery.
1 secondary outcome
Patient-Reported Breast Sensation
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
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 25 Sep 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.
Mark Sisco, MD, FACS principal investigator
Endeavor Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allogeneic Nerve Grafting in people with Breast Reconstruction Following Mastectomy, run by Endeavor Health at 3 sites in United States.
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 7 inclusion and 10 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Grace K Jukovich, MPH (847-570-1184, grace.jukovich@endeavorhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Sensation Measured by Semmes-Weinstein Monofilament Testing (time frame: Baseline, 6 months, 12 months, and 24 months after surgery). 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 25 Sep 2026.