Medical device company Hancock Jaffe has announced the end-points for its upcoming VenoValve first-in-human study in Bogota, Colombia. Endpoints for the study will include improvements in reflux time, as well as three venous clinical measurement tools: the revised Venous Clinical Severity Score (rVCSS), the Visual Analogue Scale (VAS), and the Venous Insufficiency Epidemiological and Economic Study (VEINES) instrument. The first-in-human Colombian study will initially include five to 10 patients who suffer from severe chronic venous insufficiency.
Patients will be monitored with Duplex ultrasound to measure reflux time at regular intervals during the study, with the 90-day and 180-day results being of particular importance to the company and the US Food and Drug Administration (FDA), according to the company press release. Knowledge gained from the Colombian study will be used to make any necessary design modifications to the VenoValves in preparation for a US pivotal trial.
On December 17, 2018, Hancock Jaffe announced that it had received approval for its first-in-human trial from INVIMA, the Colombian equivalent of the FDA. The company is making arrangements to import the VenoValves to Colombia, and has begun to screen patients for the study.
“We have already received more than 100 inquiries from patients in Colombia wanting to participate in our study,” said Robert Berman, Hancock Jaffe’s CEO. “Patients will be carefully screened under the supervision of Dr Jorge Hernando Ulloa, our primary investigator in Bogota, and Dr Marc H Glickman, Hancock Jaffe’s chief medical officer. Because results from the study will come relatively quickly, now is the appropriate time to begin to explain the terminology that we will be using to measure our success.”
Once initial patient enrolment is completed, Hancock Jaffe will announce the expected date for the first VenoValve implantations. The company expects to provide another update shortly after the first implantations, and a further update part of the way through the study after compiling sufficient preliminary data. Following the completion of the six-month study, the company will seek to present its data at worldwide vascular conferences and publish the data in a peer reviewed journal.
Patients will have follow-up visits and assessments approximately 14 days, 30 days, 60 days, 90 days, and 180 days after implantations of the VenoValves. Patients will be monitored for potential serious adverse events related to the device, which include thromboses, stenosis, inflammation leading to device failure, device migration, bleeding due to native vein injury or anticoagulation, and infection.