Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04866290
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2021-04-27
Brief Title:
HepaSphere Microspheres Prospective Registry
Sponsor:
Merit Medical Systems Inc
Organization:
Merit Medical Systems Inc
Study Overview
Official Title:
Prospective Registry of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver With HepaSphere Microspheres Loaded With Irinotecan
Status:
COMPLETED
Status Verified Date:
2023-03
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:
mCRC
Brief Summary:
HepaSphere Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer mCRC to the liver in 2015
The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in real life usage conditions
The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in real life usage conditions
Detailed Description:
This prospective post-market study was designed to evaluate the median overall survival MOS of subjects with metastatic colorectal cancer mCRC to the liver treated with HepaSphere Microspheres loaded with the chemotherapeutic agent irinotecan This treatment process is referred to as transarterial chemoembolization TACE
Subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior TACE for this indication were considered for study participation Patients that met eligibility criteria wanted to participate in the study and signed the informed consent form ICF made up the study subject population All study subjects were in one cohort and were not blinded to treatment
Per protocol all subjects completed a baseline visit to collect medical history information lab assessments and have a baseline MRI Following this baseline visit subjects were to have two TACE cycles ie TACE Cycle 1 TACE Cycle 2 with TACE Cycle 2 occurring within 2-4 weeks following TACE Cycle 1 A TACE cycle is defined as one TACE procedure for subjects with unilobar disease or two TACE procedures for subjects with bilobar disease ie one for each lobe of the liver Following completion of TACE Cycle 1 and TACE Cycle 2 additional TACE cycles could be performed at the investigators discretion for residual or new disease
When subjects had completed two TACE cycles and were no longer indicated for further TACE cycles at the investigators discretion they entered follow-up The study ended and analysis began when all enrolled subjects had 1 completed two-year 24 months follow-up from the date of TACE Cycle 1 2 been deemed lost to follow up or 3 died whichever occurred first
Subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior TACE for this indication were considered for study participation Patients that met eligibility criteria wanted to participate in the study and signed the informed consent form ICF made up the study subject population All study subjects were in one cohort and were not blinded to treatment
Per protocol all subjects completed a baseline visit to collect medical history information lab assessments and have a baseline MRI Following this baseline visit subjects were to have two TACE cycles ie TACE Cycle 1 TACE Cycle 2 with TACE Cycle 2 occurring within 2-4 weeks following TACE Cycle 1 A TACE cycle is defined as one TACE procedure for subjects with unilobar disease or two TACE procedures for subjects with bilobar disease ie one for each lobe of the liver Following completion of TACE Cycle 1 and TACE Cycle 2 additional TACE cycles could be performed at the investigators discretion for residual or new disease
When subjects had completed two TACE cycles and were no longer indicated for further TACE cycles at the investigators discretion they entered follow-up The study ended and analysis began when all enrolled subjects had 1 completed two-year 24 months follow-up from the date of TACE Cycle 1 2 been deemed lost to follow up or 3 died whichever occurred first
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