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

NCT05460780 | Recruiting DMC

• 1 other identifier: 3121_MATFIH22
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

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.

Conditions

Breast Cancer Female; Breast Cancer Prevent; Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

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

  Minor complications include: * Superficial skin necrosis that requires only debridement * Flap necrosis * Subcutaneous hematoma: any hematoma requiring surgical exploration * Inflammatory reaction * Seroma: defined as that which requires echo-guided puncture at least once after drain removal. * Pain * Delayed wound healing/wound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention * Implant malposition * Superficial Venous Thrombosis (Mondor disease) * Capsular contracture Major complications include: * All complications that lead to MATTISSE® TEC removal: * Skin necrosis leading to implant exposure * Infection * Implant malposition leading to implant exposure * Device failure or defect: when the implant breaks or collapses, e.g., the base separates from the shell, failure at the time of surgical placement (fracture of the TEC before placement) * Granuloma.

  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.

  Success is defined as: * Tissue expansion (flap enlargement) from implantation up to 6 months post operation --\> A 50% increase in the expanded size at 6 months compared to initial size flap is considered as a success. Indeed, the optimal growth of the flap is expected at 6 months, * Tissue expansion will be assessed using MRI at discharge (after surgery) and 6 months post operative. The volume of flap at 6 months will be compared to the flap size initially implanted. All MRI imaging will be assessed by and independent expert radiologist. Failure is defined as: * less than 50% increase in the expanded size at 6 months compared to initial size flap MATTISSE® Prothesis removal

  6 months post-surgery

Secondary Outcomes (15)

• Evolution of tissue expansion (flap enlargement) from implantation up to 36 months post operation.

  Surgery visit, 3, 6, 12, 24 and 36 months post-intervention

• Evolution of breast softness from inclusion to 36 months

  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.

  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

  3, 6, 12, 24 and 36 months post surgery

• Aesthetic breast appearance before and after surgery using photo

  3, 6, 12, 24 and 36 months post surgery

Study Arms (1)

MATTISSE TEC

EXPERIMENTAL

Patient included receive MATTISSE TEC

Device: MATTISSE TEC

Interventions

MATTISSE TEC DEVICE

Tissue engineering chamber MATTISSE

MATTISSE TEC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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:

You may not qualify 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

Sponsors & Collaborators

• Quanta Medical: lead
• Lattice Medical: collaborator

Study Sites (3)

CHU de Strasbourg

Strasbourg, France, 67091, France

RECRUITING

Hospital of Lille

Lille, Nord, 59000, France

RECRUITING

Institute of Clinical Oncology

Tbilisi, 0159, Georgia

RECRUITING

Related Publications (20)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Salzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-524. doi: 10.1097/PRS.0b013e318200a961.

  PMID: 21285756 BACKGROUND

• Morrison WA, Marre D, Grinsell D, Batty A, Trost N, O'Connor AJ. Creation of a Large Adipose Tissue Construct in Humans Using a Tissue-engineering Chamber: A Step Forward in the Clinical Application of Soft Tissue Engineering. EBioMedicine. 2016 Apr;6:238-245. doi: 10.1016/j.ebiom.2016.03.032. Epub 2016 Mar 23.

  PMID: 27211566 BACKGROUND

• Petit JY, Rietjens M, Lohsiriwat V, Rey P, Garusi C, De Lorenzi F, Martella S, Manconi A, Barbieri B, Clough KB. Update on breast reconstruction techniques and indications. World J Surg. 2012 Jul;36(7):1486-97. doi: 10.1007/s00268-012-1486-3.

  PMID: 22395342 BACKGROUND

• Cordeiro PG, McCarthy CM. A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part I. A prospective analysis of early complications. Plast Reconstr Surg. 2006 Sep 15;118(4):825-831. doi: 10.1097/01.prs.0000232362.82402.e8.

  PMID: 16980842 BACKGROUND

• Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med. 2013 May;106(5):173-7. doi: 10.1177/0141076813480994. No abstract available.

  PMID: 23761525 BACKGROUND

• Mian R, Morrison WA, Hurley JV, Penington AJ, Romeo R, Tanaka Y, Knight KR. Formation of new tissue from an arteriovenous loop in the absence of added extracellular matrix. Tissue Eng. 2000 Dec;6(6):595-603. doi: 10.1089/10763270050199541.

  PMID: 11103081 BACKGROUND

• Tanaka Y, Tsutsumi A, Crowe DM, Tajima S, Morrison WA. Generation of an autologous tissue (matrix) flap by combining an arteriovenous shunt loop with artificial skin in rats: preliminary report. Br J Plast Surg. 2000 Jan;53(1):51-7. doi: 10.1054/bjps.1999.3186.

  PMID: 10657450 BACKGROUND

• Hofer SO, Knight KM, Cooper-White JJ, O'Connor AJ, Perera JM, Romeo-Meeuw R, Penington AJ, Knight KR, Morrison WA, Messina A. Increasing the volume of vascularized tissue formation in engineered constructs: an experimental study in rats. Plast Reconstr Surg. 2003 Mar;111(3):1186-92; discussion 1193-4. doi: 10.1097/01.PRS.0000046034.02158.EB.

  PMID: 12621190 BACKGROUND

• Cronin KJ, Messina A, Knight KR, Cooper-White JJ, Stevens GW, Penington AJ, Morrison WA. New murine model of spontaneous autologous tissue engineering, combining an arteriovenous pedicle with matrix materials. Plast Reconstr Surg. 2004 Jan;113(1):260-9. doi: 10.1097/01.PRS.0000095942.71618.9D.

  PMID: 14707645 BACKGROUND

• 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 BACKGROUND

• Findlay MW, Messina A, Thompson EW, Morrison WA. Long-term persistence of tissue-engineered adipose flaps in a murine model to 1 year: an update. Plast Reconstr Surg. 2009 Oct;124(4):1077-1084. doi: 10.1097/PRS.0b013e3181b59ff6.

  PMID: 19935290 BACKGROUND

• Faglin P, Gradwohl M, Depoortere C, Germain N, Drucbert AS, Brun S, Nahon C, Dekiouk S, Rech A, Azaroual N, Maboudou P, Payen J, Danze PM, Guerreschi P, Marchetti P. Rationale for the design of 3D-printable bioresorbable tissue-engineering chambers to promote the growth of adipose tissue. Sci Rep. 2020 Jul 16;10(1):11779. doi: 10.1038/s41598-020-68776-8.

  PMID: 32678237 BACKGROUND

• Gradwohl M, Chai F, Payen J, Guerreschi P, Marchetti P, Blanchemain N. Effects of Two Melt Extrusion Based Additive Manufacturing Technologies and Common Sterilization Methods on the Properties of a Medical Grade PLGA Copolymer. Polymers (Basel). 2021 Feb 14;13(4):572. doi: 10.3390/polym13040572.

  PMID: 33672918 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Pierre GUERRESCHI, Pr

CONTACT

03.20.44.56.59; clinic@lattice-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); FR (2)