Clinical trial NCT05460780: First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Breast Cancer Prevent
Breast Reconstruction
Lead sponsor: Quanta Medical
Sponsor class: INDUSTRY
Collaborators: name: Lattice Medical
First posted: 2022-07-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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

Primary outcomes:
measure: Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded.
timeFrame: 6 months post-surgery
measure: Performance objective: To assess the efficacy at 6 months post-operation of breast reconstruction using MATTISSE® breast implants in patients undergoing breast reconstitution after total mastectomy surgery for cancer.
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Evolution of tissue expansion (flap enlargement) from implantation up to 36 months post operation.
timeFrame: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention
measure: Evolution of breast softness from inclusion to 36 months
timeFrame: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention
measure: Evolution of MATTISSE® TEC resorption until 36 months follow up: the resorption is active between 6 and 12 months after surgery.
timeFrame: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention
measure: The volume of the reconstructed breast compared to the volume of the contralateral one at 12, 24 and 36 months
timeFrame: 3, 6, 12, 24 and 36 months post surgery
measure: Aesthetic breast appearance before and after surgery using photo
timeFrame: 3, 6, 12, 24 and 36 months post surgery
measure: The maintain of breast (i.e., flap) volume stability at 12, 24 and 36 months compared to that at 6 months
timeFrame: 3, 6, 12, 24 and 36 months post surgery
measure: The impact of the flap transfer on the donor site assessed at surgery, 3, 6, 12, 24 and 36months post-surgery
timeFrame: 3, 6, 12, 24 and 36 months post surgery
measure: Pain (VAS)
timeFrame: 3, 6, 12, 24 and 36 months post surgery
measure: The quality of life and the satisfaction of patients
timeFrame: 3, 6, 12, 24 and 36 months post surgery
measure: Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure.
timeFrame: Visit 2, surgery
measure: Evolution of biological parameters up to 6 months after surgery
timeFrame: Inclusion, Discharge, 3, 6 months post-intervention
measure: Evolution of biological parameters up to 6 months after surgery
timeFrame: Inclusion, Discharge, 3, 6 months post-intervention
measure: Evolution of biological parameters up to 6 months after surgery
timeFrame: Inclusion, Discharge, 3, 6 months post-intervention
measure: Evolution of biological parameters up to 6 months after surgery
timeFrame: Inclusion, Discharge, 3, 6 months post-intervention
measure: Safety up to 36 months post operation
timeFrame: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention
Other outcomes:
Locations:
city: Lille
country: France
facility: Hospital of Lille
state: Nord
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Tbilissi
country: Georgia
facility: Institute of Clinical Oncology
Study officials:
References:
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