Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05941299
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-06-16
Brief Title:
Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy
Sponsor:
Tensive SRL
Organization:
Tensive SRL
Study Overview
Official Title:
A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy
Status:
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:
The goals of this clinical trial are
demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
demonstrate the safety and performance of REGENERA in terms of investigators satisfaction potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events
Participants will perform 13 study visits and at each visit all necessary study procedures will be performed according to the clinical investigation plan
Screening
Pre-surgery treatment
Surgery and study device implant
Post-surgery follow-up up to 5 years
demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
demonstrate the safety and performance of REGENERA in terms of investigators satisfaction potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events
Participants will perform 13 study visits and at each visit all necessary study procedures will be performed according to the clinical investigation plan
Screening
Pre-surgery treatment
Surgery and study device implant
Post-surgery follow-up up to 5 years
Detailed Description:
None
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