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Tissue Engineering

Nipple-Areola Complex Grafts for Breast Reconstruction After Cancer

N/A
Waitlist Available
Led By Geoffrey C Gurtner
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient age 18-65
Be older than 18 years old
Must not have
current BMI<18.5 or >40 kg/m
Patient has had NAC tattooing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety and healing of nipple-areola complex reconstruction using BioAesthetics' decellularized human nipple-areolar complex graft.

Who is the study for?
This trial is for breast cancer patients aged 18-65 who've had autologous breast reconstruction and want nipple-areolar complex (NAC) grafting at least 3 months later. They must not smoke, have a stable weight, avoid certain substances before healing, and be free from severe health issues or treatments like chemo.
What is being tested?
The study tests the safety and effectiveness of BioAesthetics' decellularized human NAC grafts in terms of healing time, satisfaction, well-being, self-esteem, body image, psychological state, and nipple sensitivity after surgery.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include infection at the surgery site, allergic reactions to the graft material if any sensitivities exist or complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My BMI is either below 18.5 or above 40.
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I have had nipple-areola complex tattooing.
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I am currently undergoing or have had radiation therapy to the breast area.
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I have diabetes (Type I or Type II).
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My wounds take longer to heal than usual.
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I have had nose surgery before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to healing of implanted NACgraft

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NACgraft patientsExperimental Treatment1 Intervention
uni- or bilateral engraftment surgery will be performed

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,149 Total Patients Enrolled
60 Trials studying Breast Cancer
111,034 Patients Enrolled for Breast Cancer
Geoffrey C GurtnerPrincipal InvestigatorStanford Universiy

Media Library

dcl-hNAC Graft (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT04534010 — N/A
Breast Cancer Research Study Groups: NACgraft patients
Breast Cancer Clinical Trial 2023: dcl-hNAC Graft Highlights & Side Effects. Trial Name: NCT04534010 — N/A
dcl-hNAC Graft (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534010 — N/A
~0 spots leftby Dec 2024
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