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

Launched by QUANTA MEDICAL · Jul 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the MATTISSE Tissue Engineering Chamber, specifically designed to help women who are undergoing breast reconstruction after having a mastectomy due to breast cancer. The main goal is to see how safe and effective this device is for patients. The trial is currently looking for adult women aged 18 and older who are planning to have breast reconstruction and meet certain health criteria, such as not having significant medical conditions that could affect healing.

Participants in the trial can expect to have their safety and recovery monitored closely while using this new device. They will be asked to provide informed consent and participate in questionnaires to help researchers gather important information. It’s important to note that certain women, such as those with specific health issues or who have had previous radiation treatments, may not be eligible to participate. This study aims to improve breast reconstruction options and outcomes for women facing breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion 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 surgery on the breast area or on the flap donor site
• • 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 expender removal for patient undergoing differed reconstruction.
• • 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:
• • Subjects 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;
• • Subjects affiliated to a social security schema or entitled to a social security scheme.
• Non-inclusion Criteria:
• 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.
• • EXCLUSION CRITERIA
• • 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