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RECRUITING
NCT05460780
NA

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

Sponsor: Quanta Medical

View on ClinicalTrials.gov

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

DEVICE

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