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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство MATTISSE TEC
  Tissue engineering chamber MATTISSE

Первичные конечные точки

• Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded. [Срок оценки: 6 months post-surgery]
• 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. [Срок оценки: 6 months post-surgery]

Вторичные конечные точки (12)

• Evolution of tissue expansion (flap enlargement) from implantation up to 36 months post operation. [Срок оценки: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention]
• Evolution of breast softness from inclusion to 36 months [Срок оценки: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention]
• Evolution of MATTISSE® TEC resorption until 36 months follow up: the resorption is active between 6 and 12 months after surgery. [Срок оценки: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention]
• The volume of the reconstructed breast compared to the volume of the contralateral one at 12, 24 and 36 months [Срок оценки: 3, 6, 12, 24 and 36 months post surgery]
• Aesthetic breast appearance before and after surgery using photo [Срок оценки: 3, 6, 12, 24 and 36 months post surgery]
• The maintain of breast (i.e., flap) volume stability at 12, 24 and 36 months compared to that at 6 months [Срок оценки: 3, 6, 12, 24 and 36 months post surgery]
• The impact of the flap transfer on the donor site assessed at surgery, 3, 6, 12, 24 and 36months post-surgery [Срок оценки: 3, 6, 12, 24 and 36 months post surgery]
• Pain (VAS) [Срок оценки: 3, 6, 12, 24 and 36 months post surgery]
• The quality of life and the satisfaction of patients [Срок оценки: 3, 6, 12, 24 and 36 months post surgery]
• Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure. [Срок оценки: Visit 2, surgery]
• Evolution of biological parameters up to 6 months after surgery [Срок оценки: Inclusion, Discharge, 3, 6 months post-intervention]
• Evolution of biological parameters up to 6 months after surgery [Срок оценки: Inclusion, Discharge, 3, 6 months post-intervention]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• CHU de Strasbourg — Strasbourg
• Hospital of Lille — Lille

Грузия · 1 центр

• Institute of Clinical Oncology — Tbilisi

Публикации

• Findlay MW, Dolderer JH, Trost N, Craft RO, Cao Y, Cooper-White J, Stevens G, Morrison WA. Tissue-engineered breast reconstruction: bridging the gap toward large-volume tissue engineering in humans. Plast Reconstr Surg. 2011 Dec;128(6):1206-1215. doi: 10.1097/PRS.0b013e318230c5b2. PMID 22094739
• Matsuda K, Falkenberg KJ, Woods AA, Choi YS, Morrison WA, Dilley RJ. Adipose-derived stem cells promote angiogenesis and tissue formation for in vivo tissue engineering. Tissue Eng Part A. 2013 Jun;19(11-12):1327-35. doi: 10.1089/ten.TEA.2012.0391. Epub 2013 Mar 28. PMID 23394225
• Harbeck N, Penault-Llorca F, Cortes J, Gnant M, Houssami N, Poortmans P, Ruddy K, Tsang J, Cardoso F. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66. doi: 10.1038/s41572-019-0111-2. PMID 31548545
• Schmauss D, Machens HG, Harder Y. Breast Reconstruction after Mastectomy. Front Surg. 2016 Jan 19;2:71. doi: 10.3389/fsurg.2015.00071. eCollection 2015. PMID 26835456
• Tzafetta K, Ahmed O, Bahia H, Jerwood D, Ramakrishnan V. Evaluation of the factors related to postmastectomy breast reconstruction. Plast Reconstr Surg. 2001 Jun;107(7):1694-701. doi: 10.1097/00006534-200106000-00009. PMID 11391187
• Vega S, Smartt JM Jr, Jiang S, Selber JC, Brooks CJM, Herrera HR, Serletti JM. 500 Consecutive patients with free TRAM flap breast reconstruction: a single surgeon's experience. Plast Reconstr Surg. 2008 Aug;122(2):329-339. doi: 10.1097/PRS.0b013e31817f45cb. PMID 18626347
• Duggal CS, Grudziak J, Metcalfe DB, Carlson GW, Losken A. The effects of breast size in unilateral postmastectomy breast reconstruction. Ann Plast Surg. 2013 May;70(5):506-12. doi: 10.1097/SAP.0b013e318263f1f8. PMID 23542837
• Noone RB. Thirty-five years of breast reconstruction: eleven lessons to share. Plast Reconstr Surg. 2009 Dec;124(6):1820-1827. doi: 10.1097/PRS.0b013e3181bf821a. No abstract available. PMID 19952638

Идентификаторы

NCT: NCT05460780 · 3121_MATFIH22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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