Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05533099
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-09-06
Brief Title:
REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
Sponsor:
Tensive SRL
Organization:
Tensive SRL
Study Overview
Official Title:
A Pilot Study of REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
REGENERA is a polymeric bioresorbable scaffold The REGENERA matrix is characterized by an interconnected open porevoid structure having average porevoid diameter from 03 to 65 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 polyurethane-ester- ether foam coated with a bio adhesive macromolecule PolyL- lysine PLL and hydrophobized by Oleic acid 181 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 patients 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 patients 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
The biomaterial constituting REGENERA is composed of a patented biodegradable cross-linked polyurethane-ester- ether foam coated with a bio adhesive macromolecule PolyL- lysine PLL and hydrophobized by Oleic acid 181 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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None