NCT05111795

Holmium-166 Retrospective Collection of Real-World Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 146 (actual)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.

Detailed description

This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.

Conditions

• Hepatocellular Carcinoma
• Metastatic Cancer

Interventions

Type	Name	Description
DEVICE	Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres	SIRT work-up procedure and SIRT procedure

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-02-15
• Completion: 2022-04-08
• First posted: 2021-11-08
• Last updated: 2022-08-30

Locations

12 sites across 7 countries: Belgium, Germany, Italy, Netherlands, Portugal, Spain, Switzerland