Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817175
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-04-04
Brief Title:
International Prospective REgistry on Pre-pectorAl Breast REconstruction
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
International Prospective REgistry on Pre-pectorAl Breast REconstruction
Status:
RECRUITING
Status Verified Date:
2024-05
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:
I-PREPARE
Brief Summary:
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer The aim of the study is to collect data on the surgical aesthetic and oncological results as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach
Detailed Description:
1236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled Being an observational study the diagnostic-therapeutic path of the patients will not be modified in any way Therefore no risks are anticipated for the patients who will participate in this study Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed in particular the most appropriate type of technique in the pre-pectoral approach
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