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NCT04534010 · ClinicalTrials.gov registry record · NA
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT04534010: Clinical Trial NA study, sponsored by Stanford University.
NCT04534010 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534010, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.
Primary Outcome
Complete is defined as when the graft is \>99% epithelialized. 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.
Interventions
- DEVICE NACgraft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2024-11-21 |
| Phase | NA |
Why NCT04534010 stopped before completion
NCT04534010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which NACgraft is the first listed.
NCT04534010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534010 about?
NCT04534010 is a clinical study titled "Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts". The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will ...
What is the current status of trial NCT04534010?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2021-04-28. Estimated completion is 2024-11-21.
What interventions are being tested in trial NCT04534010?
The interventions under investigation include: NACgraft (DEVICE).
Who is sponsoring clinical trial NCT04534010?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534010's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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