Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04534010 |
Recruitment Status :
Recruiting
First Posted : September 1, 2020
Last Update Posted : May 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Device: NACgraft | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft |
Actual Study Start Date : | April 28, 2021 |
Estimated Primary Completion Date : | April 15, 2024 |
Estimated Study Completion Date : | April 15, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: NACgraft patients
uni- or bilateral engraftment surgery will be performed
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Device: NACgraft
Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts. A NACgraft is a novel decellularized cadaveric implant derived from human nipples. |
- Time to healing of implanted NACgraft [ Time Frame: 14 months ]Time to healing for each NACgraft will be as the first weekly visit at which the surgeon and central reviewer deem the graft >99% epithelialized. This measurement will be reported as the number of weeks to healing. Degree of healing will be based on visual assessment by the surgeon and central reviewer with the following metrics on a visual analog scale (VAS): epithelialization (0-100%); granulation (0-100%); overall healing (0-100%). Photographs will be taken using a standardized 3d imaging device, stored and transmitted securely to a central reviewer for independent review. Time to complete healing will be defined as the first visit at which the surgeon and independent reviewer determine that there is >99% epithelialization of the graft.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patient age 18-65
- Patient desires NAC grafting ≥3 months after autologous breast reconstruction
- Patient agrees to sleep on back until grafts healed (6 weeks)
- Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks)
- Patient agrees to not undergo NAC tattooing until completing study (12 months)
- Patient is able to understand and willing to sign informed consent.
Exclusion Criteria:
- History of delayed wound healing
- history of Vitamin C deficiency
- history of diabetes (Type I or Type II)
- current BMI<18.5 or >40 kg/m,
- patient has any other uncontrolled comorbidity.
- Patient has a history of allergic reaction to any decellularized biologic matrix product.
- Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months.
- Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall.
- Patient has a history of prior NAC reconstruction
- Patient has had NAC tattooing.
- Patient is pregnant, breastfeeding or planning to become pregnant during the study period.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534010
Contact: Shannon Meyer | 650-724-1953 | smeyer27@stanford.edu |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94304 | |
Contact: Shannon Meyer 650-724-1953 smeyer27@stanford.edu | |
Principal Investigator: Geoffrey C Geoffrey |
Principal Investigator: | Geoffrey C Gurtner | Stanford Universiy |
Responsible Party: | Arash Momeni, Assistant Professor of Surgery, Stanford University |
ClinicalTrials.gov Identifier: | NCT04534010 |
Other Study ID Numbers: |
IRB-55153 BRS0117 ( Other Identifier: OnCore ) |
First Posted: | September 1, 2020 Key Record Dates |
Last Update Posted: | May 18, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |