Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
Public ClinicalTrials.gov record NCT07819357. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Blinded, Within-Subject Trial of Allogeneic Nerve Grafting After Bilateral Nipple-Sparing Mastectomy With Implant-Based Reconstruction
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07819357
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2026
- Primary completion
- Nov 30, 2030
- Completion
- Nov 30, 2030
- Last update posted
- Sep 13, 2026
2026 – 2030
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Evanston Hospital | Evanston | Illinois | 60201 | — |
| Highland Park Hospital | Highland Park | Illinois | 60035 | — |
| 501 Skokie Blvd Ste 250 | Northbrook | Illinois | 60062 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07819357, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 13, 2026 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07819357 live on ClinicalTrials.gov.