NCT05460780

First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Quanta Medical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Female
• Breast Cancer Prevent
• Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	MATTISSE TEC	Tissue engineering chamber MATTISSE

Timeline

• Start date: 2022-07-01
• Primary completion: 2027-07-31
• Completion: 2028-12-31
• First posted: 2022-07-15
• Last updated: 2025-03-20

Locations

3 sites across 2 countries: France, Georgia