Status:
COMPLETED
HepaSphere™ Microspheres Prospective Registry
Lead Sponsor:
Merit Medical Systems, Inc.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
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...
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 lo...
Eligibility Criteria
Inclusion
- Histologically or radiologically confirmed colorectal cancer metastases to the liver
- Patient is able to have either CT or MRI imaging
- Hepatic tumor burden ≥50% of total tumor burden
- Hepatic tumor burden ≤50% of total liver volume
- Not suitable for treatment by resection or percutaneous ablation at time of TACE treatment
- Life expectancy ≥ 3 months
- WHO performance status ≤ 2
Exclusion
- Previous treatment with any form of hepatic transarterial embolization
- Total bilirubin ≥ 3.0 mg/dL
- Any contraindication for irinotecan administration
- Partial or complete thrombosis of the main portal vein
- Cardiovascular or respiratory failure
- Any other condition deemed exclusionary by the Investigator
Key Trial Info
Start Date :
September 22 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04866290
Start Date
September 22 2016
End Date
June 1 2021
Last Update
April 3 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
European Hospital Georges Pompidou
Paris, France, 75015
2
Evgenidio Hospital/ATTIKO Hospital
Athens, Greece, 11528