RecruitingNot ApplicableNCT05460780

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


Sponsor

Quanta Medical

Enrollment

50 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new tissue engineering device called MATTISSE — a chamber implanted under the skin that uses your body's own healing process to grow new breast tissue — for women reconstructing a breast after mastectomy. It's an alternative to implants or tissue flap surgery. **You may be eligible if...** - You are female and over 18 years old - You have had or will have a mastectomy for early-stage breast cancer or as a preventive measure - You need or want breast reconstruction on one side - You are having immediate or delayed reconstruction **You may NOT be eligible if...** - You need reconstruction on both breasts - You have had prior radiation to the chest wall (in some cases) - You have conditions that affect wound healing (e.g., uncontrolled diabetes) - You smoke heavily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMATTISSE 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05460780


Related Trials