Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04131972
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2019-05-14
Brief Title:
REGENERA Implant in Excised Non-Malignant Breast Lesions
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
Status:
COMPLETED
Status Verified Date:
2022-02
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:
The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA
Detailed Description:
This is a pre-market single center interventional open label non-comparative pilot first-in-human study on adult female patients with localized non-malignant breast lesion This study will include an enrollment period of 12 months and 6 months study duration per patient
The primary objective of this study is to demonstrate the safety profile of a new breast implant REGENERA in excision or lumpectomy of non-malignant breast lesions
The secondary objectives of this study are
To assess the safety of the implant procedure
To assess the feasibility of the implant procedure
To evaluate the performance of REGENERA breast implant
In replacing the removed tissue
In potential interference with current diagnostic standard of care imaging procedures
On patients quality of life and satisfaction
On investigators satisfaction
The primary objective of this study is to demonstrate the safety profile of a new breast implant REGENERA in excision or lumpectomy of non-malignant breast lesions
The secondary objectives of this study are
To assess the safety of the implant procedure
To assess the feasibility of the implant procedure
To evaluate the performance of REGENERA breast implant
In replacing the removed tissue
In potential interference with current diagnostic standard of care imaging procedures
On patients quality of life and satisfaction
On investigators satisfaction
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