A Phase 4 interventional study of Allogeneic Nerve Grafting in Breast Reconstruction Following Mastectomy, sponsored by Endeavor Health. Not yet recruiting at 3 sites in United States. Open to female participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Endeavor Health · Phase 4, Interventional, and Treatment
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:
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:
Endeavor Health is the lead sponsor of 111 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Allogeneic Nerve Grafting
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.
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.
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.
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
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.
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
Neurotization-Related Complications
The occurrence of complications plausibly related to the nerve grafting procedure will be assessed, including neuropathic pain and neuroma formation.
Time frame: From surgery through 24 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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