Clinical trials: Reconstruction of the Breast Nipple and Areola Complex
Breast Cancer
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…
- Trial name
- NCT04534010
- Testing
- NACgraft
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Stanford University
Mastectomy, Breast Reconstruction
Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240…
- Trial name
- RMR (NCT04457167)
- Testing
- Robot-assisted, Not robot-assisted surgery
- Where
- France
- Volunteers
- 480 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer, Breast Reconstruction
EndoBreast Study - Assessment of Feasibility, Functional Outcomes, and Sensitivity of the Areola-Nipple Complex in Endoscopic Mastectomy
Study Design Prospective, single-center, observational, non-interventional study conducted in routine clinical practice. No investigational treatments or modifications to standard diagnostic, therapeutic, or follow-up procedures…
- Trial name
- EndoBreast (NCT07718425)
- Testing
- endoscopic mastectomy
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Massimiliano Bortolini
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
BIOCHROMADERM® PMCF STUDY
The goal of this observational study is to: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; To confirm the…
- Trial name
- NCT07261904
- Where
- 3 sites in France
- Volunteers
- 115 people
- Sponsor
- Laboratoires BIOTIC Phocea
Breast Cancer, Ductal Carcinoma
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
- Trial name
- NCT01208974
- Testing
- Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Miami
Reconstruction of the Breast Nipple and Areola Complex
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
- Trial name
- NCT04051892
- Testing
- FixNip™ NRI
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- FixNip Ltd