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 email@example.com.