First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
Recruiting
N/A
Interventional Study
Breast Cancer Female
Breast Cancer Prevent
Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 50 (estimated)
- Sponsor
- Quanta Medical · Industry
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About This Trial
This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Criteria related to pathology:
* Female patient over 18 Years old
* Patient who required autologous breast reconstruction:
* Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
* Breast reconstruction after unilateral preventive total m…
Contacts