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New treatment option for Breast Cancer Female
Official title First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
ClinicalTrials.gov ID: NCT05460780
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Criteria related to pathology:
- Female patient over 18 Years old
- Patient who required autologous breast reconstruction:
- Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
- Breast reconstruction after unilateral preventive total mastectomy
You likely can't join if
- Positive or suspicious extemporaneous sentinel node biopsy
- Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler
- Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment
See the full eligibility criteria
- Criteria related to pathology:
- Female patient over 18 Years old
- Patient who required autologous breast reconstruction:
- Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
- Breast reconstruction after unilateral preventive total mastectomy
- or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation
- or conversion from implant-based to autologous reconstruction: Patient who had a breast implant during a previous reconstruction after total mastectomy for cancer, and who needs to change it.
- For patient with active cancer: Patient with early-stage cancer (stage 0, I or II, with tumor size \< 50mm, without lymph-node involvement) needing oncological management that does not required radiotherapy after...
- Patient who required Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion; or implant removal for patient undergoing autologous conversion, or...
- Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.
- Patient medically fit for surgery without significant comorbidities
- Breast cup-size less than D
- Body mass index \>20 kg/m2 or patient for whom sufficient flap volume is expected according to surgeon's assessment
- Adequate hematopoietic functions Criteria related to population:
- people who have given free, informed and written consent to participate in the study;
- Patient able to answer questionnaires, able to communicate in the language of the study country;
- people affiliated to a social security schema or entitled to a social security scheme. Non- Pathology related criteria:
- Patient undergoing bilateral reconstruction
- Patient undergoing bilateral preventive mastectomy
- Patient undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation
- Previous history of radiotherapy on the breast area or on the flap donor site
- Previous history of breast or axillary surgery that does not allow fat flap dissection
- Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI
- Body mass index \>30 kg/m2
- Taking medication for weight loss at the time of inclusion visit
- Presence of major medical conditions that may compromise patient's health and healing
- Diabetes and a history of gestational diabetes
- Active smoking
- Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)
- Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination
- Allergy to anesthetics or contrast media
- Immunocompromised patient (HIV) or patient used immunosuppressants Population related criteria
- Pregnant patient
- or breastfeeding patient or woman who has nursed a child three months within inclusion
- Participation in a clinical trial in the 3 months prior to the initial visit
- Predicted unavailability during study.
- Patient deprived of liberty or under guardianship.
- Patient unable to give consent Medical device related criteria
- Allergy to any of the components of the medical device.
- Positive or suspicious extemporaneous sentinel node biopsy
- Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler
- Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France, France
- Lille, Nord, France
- Tbilisi, Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France, France; Lille, Nord, France; Tbilisi, Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.