TIDE clinical trial FAQ: we answer your questions!

TIDE clinical trial FAQ: we answer your questions!

1- What is the TIDE study?

The TIDE study evaluates the efficacy and safety of the new MATTISSE breast implant developed by LATTICE MEDICAL. This is the First-In-Human study of MATTISSE on human patients.

2- How does MATTISSE work?

MATTISSE is a 3D-printed, resorbable tissue engineering chamber for breast reconstruction.
After mastectomy, an adipose flap is harvested from beneath the sub-mammary fold and implanted in the tissue-engineered chamber. The aim of the MATTISSE device is to enable regeneration of this adipose flap. The TIDE study aims to evaluate the percentage of growth (tissue regeneration) of this flap, as well as the complication rate associated with implantation of this device.

3- What are the advantages of participating in the TIDE study?

Participation in the TIDE study offers the opportunity to benefit from autologous breast reconstruction. This means that your breast will be reconstructed using a prosthesis that allows your own tissue to grow.

4- How can I participate in the TIDE study?

The duration of the study is 36 months. Data will be collected anonymously for the duration of the study. A consent form must be signed with your doctor if you wish to participate. Your participation is free and voluntary, and you may withdraw from the study at any time.

5- Where can I find the list of investigator centers currently open?

You can find the investigating centers currently open to the TIDE clinical study on the Lattice Medical website by following this link.

6- What are the main inclusion and non-inclusion criteria for participation in the TIDE study?

Inclusion criteria:

• Female patients over 18 years of age
• Patients requiring autologous breast reconstruction:
  o Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
  o Breast reconstruction after preventive unilateral total mastectomy or deferred unilateral reconstruction after total mastectomy for early-stage breast cancer with tissue expander implantation
  o Conversion to autologous: Patients who have had a breast implant during a previous reconstruction after a total mastectomy for cancer, and who need to change it.
• Patients who have given free, informed and written consent to participate in the study.

Non-inclusion criteria :

• Patients undergoing bilateral reconstruction
• Patients undergoing bilateral preventive mastectomy
• History of radiotherapy to the breast area or flap donor site
• Active smoker
• Participation in a clinical trial in the 3 months prior to the first visit If you do not meet the inclusion criteria, you can ask your doctor or gynecological surgeon about other breast reconstruction alternatives.

7- Is the MATTISSE device compatible with radiotherapy?

If you have had a history of radiotherapy in the breast area or flap harvest area, you cannot be included in the study.
If your stage of cancer will ultimately require radiotherapy after breast reconstruction, you will not be eligible for inclusion in the study.

8- Is the MATTISSE device compatible with chemotherapy?

Yes, it is compatible, this is not a criterion for exclusion.

9- What are the possible risks and/or complications?

Possible complications of the implant include minor risks such as tissue damage, superficial skin or flap necrosis (condition in which cells, infection, extrusion (exit of the implant through the skin), implant displacement or implant malposition up to and including implant exposure, inflammatory reaction, sensitivity disorders, implant deformation, hematoma / seroma (accumulation of blood or fluid around the implant), surgical procedure-related complications, for example: artificial venous thrombosis (Mondor disease), capsular contraction (rigid breast, as a firm capsule is formed around the implant), early explantation, moderate chronic pain, distortion of implant shape, healing disorder, rupture.

These are potentially expected risks, which can be observed with other reconstruction techniques. The investigating surgeon is therefore used to dealing with this type of complication, based on experience with other techniques.

10- Where can I fill in the questionnaire to take part in the TIDE study?

You can fill in a pre-eligibility questionnaire to take part in the TIDE study by following this link on our website.

You can also contact the TIDE clinical researchers at Lille University Hospital directly for more information. Their contact details are available on our website.

11- What happens to your data after the study?

Your data will be processed by Voisin Consulting Life Sciences, the company responsible for data processing. They will be anonymized using an identification number known only to your doctor. Lattice Medical will be responsible for the final storage of your data.

For further information, please consult your doctor or gynecological surgeon, or visit our website.