A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
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|ClinicalTrials.gov Identifier: NCT01677624|
Recruitment Status : Completed
First Posted : September 3, 2012
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypervascular Tumor and Arteriovenous Malformation||Device: E7040||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
- Success Rate of Embolization in the Target Vessel [ Time Frame: Day 1 (embolization) up to Day 30 after treatment ]Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.
- Success Rate for Operability of Embolization [ Time Frame: Day 1 (embolization) up to Day 30 after treatment ]Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677624
|Hirosaki, Aomori, Japan|
|Chikushino, Fukuoka, Japan|
|Kurume, Fukuoka, Japan|
|Nishinomiya, Hyogo, Japan|
|Kanazawa, Ishikawa, Japan|
|Tsu, Mie, Japan|
|Chuo-ku, Tokyo, Japan|
|Minato-ku, Tokyo, Japan|
|Study Director:||Shin Maeda||Oncology Clinical Development Section Japan/Asia Clinical Research Product Creation Unit Eisai Product Creation Systems|