Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05533099 |
| Other study ID # |
Tens-BBC/002/2020 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 27, 2021 |
| Est. completion date |
May 17, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Tensive SRL |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15
patients treated for breast deformities following excision or lumpectomy. The technique was
minimally invasive, easily repeated and associated with minimal surgical morbidity.
It is important to assess whether the positive safety and performance results obtained during
the initial 6 months post- surgery are maintained in the long-term, for up to 5 years after
surgery.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA
implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
Description:
REGENERA is a polymeric bioresorbable scaffold. The REGENERA matrix is characterized by an
interconnected open pore/void structure, having average pore/void diameter from 0.3 to 6.5 mm
and local thickness of 30 μm ± 20 μm (μCT 50, SCANCO Medical AG, Brüttisellen, Switzerland).
A network of channels is embedded into the porous structure according to a specific pattern,
where the channels are interconnected with the porous structure.
The biomaterial constituting REGENERA is composed of a patented biodegradable cross-linked
poly(urethane-ester- ether) foam coated with a bio adhesive macromolecule [Poly(L- lysine);
PLL] and hydrophobized by Oleic acid (18:1 n-9), a monounsaturated fatty acid.
The shape and geometry of REGENERA have been set to facilitate its insertion to the
implantation site and to fulfill the volume deficit caused by excision of lesioned soft
tissue after lumpectomy.
REGENERA is a polymeric bioresorbable scaffold intended to support the ingrowth of the
patient's soft tissue when used to restore the natural appearance of the breast after
surgical removal of benign and malignant breast lesions, up to 200 cc in volume.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA
implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
REGENERA is the first medical device designed to restore a natural breast, after
breast-conserving surgery (lumpectomy). As shown by the preliminary results of the FIH pilot
study, a natural shape and feeling could be achieved, based on the patient's soft tissue
growth ability, in a single step, easy-to- adopt and, potentially, cost saving procedure, for
the healthcare stakeholders. The few post-operative complications combined with the positive
psychological impact generated by the existence of a valid reconstructive option after
lumpectomy, has the potential to improve the patients' quality of life, during and after
post-surgery recovery.
Because all of that, the purpose of this long-term follow-up study is to assess whether
REGENERA does not cause long-term safety issues and confirms its performance in the
long-term.
