TheraSphere Japan Pre-Market Study
ConditionLiver Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
Eligibility criteria
Qualifiers
Patient aged >18 years at time of consent
Patient is able and willing to participate in the study and has provided written informed consent
Patient who is determined to have failed or not be eligible for standard treatment by the multidisciplinary board
Primary or secondary liver cancer (by histology or imaging)
Disqualifiers
Vp4 according to the Liver Cancer Study Group of Japan (LCSGJ) portal vein tumor thrombosis classification1
History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically.
Contraindications to angiography and selective visceral catheterization
Received any prior external beam radiation treatment to the liver
Trial design
Treatments tested in this trial
- TheraSphere Y-90 glass microsphere
Treatment groups
51 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov