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

Breast Cancer Female Clinical Trial

— TIDE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460780
• Other study ID #: 3121_MATFIH22
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: Quanta Medical
• Contact: Pierre GUERRESCHI, Pr
• Phone: 03.20.44.56.59
• Email: clinic[@]lattice-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2028
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Breast Reconstruction

Intervention

Device:
• MATTISSE TEC
Tissue engineering chamber MATTISSE

Locations

Country	Name	City	State
France	Hospital of Lille	Lille	Nord
France	CHU de Strasbourg	Strasbourg
Georgia	Institute of Clinical Oncology	Tbilissi

Sponsors (2)

Lead Sponsor	Collaborator
Quanta Medical	Lattice Medical

Countries where clinical trial is conducted

France,  Georgia, 

References & Publications (20)

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.0000232362.8240 — View Citation

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. d — View Citation

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. — View Citation

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 pro — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 Su — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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.0b013e318200a96 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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.0b013e31817f45 — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Evolution of tissue expansion (flap enlargement) from implantation up to 36 months post operation.	Tissue expansion will be assessed using MRI at discharge (after surgery), 12, 24 and 36 months post operative.; All MRI imaging will be assessed by and independent expert radiologist.	Surgery visit, 3, 6, 12, 24 and 36 months post-intervention
Secondary	Evolution of breast softness from inclusion to 36 months	The breast softness will be assessed by investigator surgeon and patients themselves at discharge (after surgery), 3, 6 ,12, 24 and 36 months as: Stage 1: Breast is soft; Stage 2: Breast is hard; Stage 3: Breast is hard with distortion; Stage 4: Breast is hard, painful with distortion	Surgery visit, 3, 6, 12, 24 and 36 months post-intervention
Secondary	Evolution of MATTISSE® TEC resorption until 36 months follow up: the resorption is active between 6 and 12 months after surgery.	MATTISSE® TEC resorption will be observed quantitatively on MRI achieved at 3, 6, 12, 24 and 36 months associated with the touch of the surgeon and patients feeling. The TEC resorption will be classified as: Absent: no resorption at all.; Small resorption: TEC has been reabsorbed a little bit compared to the initial; Great resorption: TEC has been absorbed a lot but not totally; Total: Shell and base are no longer visible on the MRI and not felt by the surgeon	Surgery visit, 3, 6, 12, 24 and 36 months post-intervention
Secondary	The volume of the reconstructed breast compared to the volume of the contralateral one at 12, 24 and 36 months	At 12, 24 and 36 months, we will assess during physical examinations, the volume of the reconstructed breast and the volume of the contralateral one.	3, 6, 12, 24 and 36 months post surgery
Secondary	Aesthetic breast appearance before and after surgery using photo	Aesthetic breast appearance will be assessed before surgery, 6 at 12, 24 and 36 months post-surgery using standardized photographs. The assessment will be done by the surgeon and 2 independent external specialists who validated standardized photographs.; The following scoring points will be used: Excellent: Treated breast nearly identical to that before surgery; Good: Treated breast slightly different to that before surgery; Fair: Treated breast clearly different to that before surgery but not seriously distorted; Poor: Treated breast seriously distorted compared to that before surgery	3, 6, 12, 24 and 36 months post surgery
Secondary	The maintain of breast (i.e., flap) volume stability at 12, 24 and 36 months compared to that at 6 months	Flap volume at 12, 24 and 36 months is compared at that assessed at 6 months using MRI.; All MRI imaging will be assessed by and independent expert radiologist.	3, 6, 12, 24 and 36 months post surgery
Secondary	The impact of the flap transfer on the donor site assessed at surgery, 3, 6, 12, 24 and 36months post-surgery	Impact of the flap transfer on the donor site will be assessed at surgery, 3, 6, 12, 24 and 36 months post-surgery using different parameters: Tissue necrosis (Yes/ No); Symmetry of the donor site area (comparing to the other side of the patient): Yes/ No	3, 6, 12, 24 and 36 months post surgery
Secondary	Pain (VAS)	Pain score will be assessed at inclusion, discharge, 3, 6, 12, 24 and 36 month using a 10 Visual Analogue Scale [VAS, 0 (no pain) and 10 (worst possible pain)]	3, 6, 12, 24 and 36 months post surgery
Secondary	The quality of life and the satisfaction of patients	Quality of life and patients' satisfaction will be done through the BREAST-Q© questionnaire (module of reconstruction pre and post-surgery version) at inclusion and at 3, 6 and 12 months post operative. The quality of life is evaluated through 2 scales (psychological well-being and physical well-being: breast).; The satisfaction is evaluated with 1 scale : (satisfaction with breast).	3, 6, 12, 24 and 36 months post surgery
Secondary	Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure.	- Surgeons' satisfaction regarding the use of MATTISSE® TEC and implantation procedure will be assessed on: Global satisfaction of the surgeon (5 points Likert scale); Ease of use; Material ergonomics; Ease of insertion; Ease of fixing	Visit 2, surgery
Secondary	Evolution of biological parameters up to 6 months after surgery	Complete blood counts evolution will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by measuring Hemoglobin , leukocytes Lymphocyte rate Neutrophil rate and Thrombocytes; Units: Hemoglobin : g/L; leukocytes :10?/L; Lymphocyte rate : %; Neutrophil rate : %; Thrombocytes : 10?/L	Inclusion, Discharge, 3, 6 months post-intervention
Secondary	Evolution of biological parameters up to 6 months after surgery	C-reactive protein evolution will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by measuring CRP; Unit: - CRP : nmoL/L	Inclusion, Discharge, 3, 6 months post-intervention
Secondary	Evolution of biological parameters up to 6 months after surgery	Total protein evolution will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by total protein assay; Unit: Total protein: Normal or Not normal	Inclusion, Discharge, 3, 6 months post-intervention
Secondary	Evolution of biological parameters up to 6 months after surgery	Protein electrophoresis will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by performing protein electrophoresis.; Unit : Protein electrophoresis: Normal or Not normal	Inclusion, Discharge, 3, 6 months post-intervention
Secondary	Safety up to 36 months post operation	Safety up to 36 months, will be assessed by measuring the complication rate after breast reconstruction using MATTISSE® TEC. Adverse events up to 36 months post operation will be recorded.	Surgery visit, 3, 6, 12, 24 and 36 months post-intervention

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