Syntheon neurovascular medical device first-in-man clinical trial in Colombia

Syntheon designs and develops medical devices. Its website is available at www.syntheon.com.

Syntheon is presently working on a neurovascular device for mechanical thrombectomy. Syntheon wants to begin a first-in-human use clinical trial of ~10 patients. Syntheon thinks Colombia may be the right place for the trial and is looking for a high-volume stroke center with mechanical thrombectomy experience.

Syntheon is looking for a principal investigator and research center in Colombia. It must be a high-volume stroke center that performs >100 mechanical thrombectomies/year. Syntheon projects that such a volume would give them at least 2 opportunities per week to recruit patients for its trial. 

For this, Syntheon has the following questions to the candidate principal investigator to determine the feasibility of the study:

  • Do you perform mechanical thrombectomy for stroke cases?
  • If so, about how many stroke cases per year?
  • What is your preferred method (stent retriever, aspiration only, Solumbra, etc)?
  • How often dos the institutional review board (IRB) or ethics committee (EC) at the research center meet?
  • Have you done any neurovascular clinical trials?

Please send your answers to info@bioaccessla.com.