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Breast Cancer FemaleTIDENCT05460780

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

A study testing MATTISSE TEC in people with Breast Cancer Female and Breast Cancer Prevent, run by Quanta Medical at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
MATTISSE TEC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesin 2 countries
Study dates
1 Jul 2022to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 44Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pierre GUERRESCHI, Pr contact

03.20.44.56.59

clinic@lattice-medical.com

3 sites in 2 countries

France2 sites, 2 recruiting

  • Hospital of Lille

    Lille, Nord, 59000

    Pierre Guerreschi, Prof.

    Recruiting

  • CHU de Strasbourg

    Strasbourg, France, 67091

    Frédéric BODIN, Pr

    Recruiting

Other trials in France

Georgia1 site, 1 recruiting

  • Institute of Clinical Oncology

    Tbilisi, 0159

    Gia NEMSADZE, Pr

    Recruiting

Other trials in Georgia

About this study

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

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.

Being tested
MATTISSE TEC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MATTISSE TECDevice

    Tissue engineering chamber MATTISSE

Study groups in NCT05460780
Study groupRoleWhat they receive
MATTISSE TECExperimentalPatient included receive MATTISSE TEC
Receives: Device: MATTISSE TEC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months post-surgery

  2. 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

    Measured: 6 months post-surgery

Secondary outcomes (15)

  1. 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.

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

  2. 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

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

  3. 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

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

  4. 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.

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

  5. 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

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

  6. 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.

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

  7. 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

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

  8. 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)]

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

  9. 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).

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

  10. 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

    Measured: Visit 2, surgery

  11. 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 :10⁹/L
    • Lymphocyte rate : %
    • Neutrophil rate : %
    • Thrombocytes : 10⁹/L

    Measured: Inclusion, Discharge, 3, 6 months post-intervention

  12. 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

    Measured: Inclusion, Discharge, 3, 6 months post-intervention

  13. 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

    Measured: Inclusion, Discharge, 3, 6 months post-intervention

  14. 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

    Measured: Inclusion, Discharge, 3, 6 months post-intervention

  15. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start1 Jul 2022
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05460780
Sponsor's protocol ID
3121_MATFIH22
Acronym
TIDE
Status last verified
Oct 2024
First submitted
12 Jul 2022
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 19952638

  • 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.

    PubMed 21285756

  • 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.

    PubMed 27211566

  • 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.

    PubMed 22395342

  • 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.

    PubMed 16980842

  • 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.

    PubMed 23761525

  • 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.

    PubMed 11103081

  • 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.

    PubMed 10657450

Questions about this trial

What is this clinical trial studying?

A study testing MATTISSE TEC in people with Breast Cancer Female and Breast Cancer Prevent, run by Quanta Medical at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pierre GUERRESCHI, Pr (03.20.44.56.59, clinic@lattice-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded. (time frame: 6 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05460780, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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