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First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
Sponsor: Quanta Medical
Summary
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.
Official title: First-in-human Study of MATTISSE® Tissue Engineering Chamber in Adult Female After Total Mastectomy for Breast Cancer in Immediate or Delayed 2-stage Tissue Expander Reconstruction or Conversion From Implant-based to Autologous Reconstruction
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-07-01
Completion Date
2028-12-31
Last Updated
2025-03-20
Healthy Volunteers
No
Interventions
MATTISSE TEC
Tissue engineering chamber MATTISSE
Locations (3)
CHU de Strasbourg
Strasbourg, France, France
Hospital of Lille
Lille, Nord, France
Institute of Clinical Oncology
Tbilisi, Georgia