First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
NCT05460780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-03-20
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
- DEVICE
-
MATTISSE TEC
Tissue engineering chamber MATTISSE
Sponsors & Collaborators
-
Lattice Medical
collaborator UNKNOWN -
Quanta Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2027-07-31
- Completion
- 2028-12-31
Countries
- France
- Georgia
Study Locations
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