Actively Recruiting
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
Led by Quanta Medical · Updated on 2025-03-20
50
Participants Needed
3
Research Sites
339 weeks
Total Duration
On this page
Sponsors
Q
Quanta Medical
Lead Sponsor
L
Lattice Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient over 18 years old
- Patients requiring autologous breast reconstruction including immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
- Breast reconstruction after unilateral preventive total mastectomy
- Delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with tissue expander implantation
- Conversion from implant-based to autologous reconstruction after previous breast implant reconstruction
- Early-stage cancer (stage 0, I or II) with tumor size less than 50mm and no lymph-node involvement, not requiring radiotherapy after surgery
- Nipple sparing or skin sparing mastectomy with a single surgical approach
- Autologous reconstruction using LICAP or LTAP flap if LICAP is not possible
- Medically fit for surgery without significant comorbidities
- Breast cup-size less than D
- Body mass index greater than 20 kg/m2 or expected sufficient flap volume
- Adequate hematopoietic functions
- Able to give free, informed, written consent
- Able to answer questionnaires and communicate in the study country's language
- Affiliated or entitled to a social security scheme
You will not qualify if you...
- Undergoing bilateral reconstruction or bilateral preventive mastectomy
- Undergoing simultaneous contralateral breast reduction, mastopexy, or augmentation
- Previous radiotherapy on the breast area or flap donor site
- Previous breast or axillary surgery preventing fat flap dissection
- Presence of pacemaker or metallic prosthesis incompatible with MRI
- Body mass index greater than 30 kg/m2
- Taking medication for weight loss at inclusion
- Major medical conditions compromising health or healing
- Diabetes or history of gestational diabetes
- Active smoking
- Microangiopathy, vascular diseases, or systemic diseases like Raynaud's
- Infection or alteration of surgical site confirmed before surgery
- Allergy to anesthetics or contrast media
- Immunocompromised or using immunosuppressants
- Pregnant or breastfeeding or nursing within 3 months
- Participation in another clinical trial within 3 months prior
- Predicted unavailability during study
- Deprived of liberty or under guardianship
- Unable to give consent
- Allergy to any component of the medical device
- Positive or suspicious sentinel node biopsy
- Non-integrity of LICAP or LTAP vessels shown by pre-operative doppler
- Cancer stage requiring radiotherapy after MATTISSE implantation not yet done
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
CHU de Strasbourg
Strasbourg, France, France, 67091
Actively Recruiting
2
Hospital of Lille
Lille, Nord, France, 59000
Actively Recruiting
3
Institute of Clinical Oncology
Tbilisi, Georgia, 0159
Actively Recruiting
Research Team
P
Pierre GUERRESCHI, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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