SCIENTIFIC COMMUNITY
Making the impossible possible.
For the Scientific Community
Requests for Research Collaboration
Insightec is committed to collaborating with healthcare professionals to promote and extend knowledge in the field of focused ultrasound (FUS) technology. In our mission, making the impossible possible, we believe that our efforts are strengthened through partnerships with those who share that vision. Insightec considers research partnerships with healthcare professionals in two ways:
Participation in company-sponsored studies
Investigator-initiated studies
We welcome the submission of interest and proposals from qualified individuals through our online portal, which can be accessed through the links below. For more information about the submission process, please connect with Insightec’s medical science team at msl@insightec.com.
Company-sponsored studiesINSPIRE: INsightec SPonsored Innovative Research Program
Insightec collaborates with key scientific partners to explore FUS in indications relevant to the company’s areas of strategic interest. If your institution is interested in serving as a study site for future sponsored trial and can demonstrate clinical research capabilities, please submit investigator and institutional information through our secure portal.
At the time of site identification for new studies, Insightec will review the resources of each investigator/institution in relation to the planned study activities through a competitive site-selection process.
Investigator-initiated studiesThe INITIATE Program: INsightec InvesTigator InitiAted Trial & Exploration Program
Investigator-initiated studies play an important role in addressing key medical and scientific questions in Insightec’s areas of strategic interest. Insightec greatly values the innovation and expertise of scientific institutions and is committed to collaborating with qualified sponsors in research aimed at extending knowledge in the field of FUS. We welcome unsolicited proposals from qualified investigators through a two-step process via our secure, online portal. Insightec will review the study concept based on scientific relevance/merit, quality, compliance, and alignment with company priorities and resources within 60 days of concept submission. The applicant will be notified of the outcome and may be invited to submit a final protocol for consideration by Insightec’s research committee.
Please note that all investigator-initiated proposals should be for the use of the Exablate Neuro (650 kHz, high-intensity) system. With this system, priorities will be given to projects focusing on the following therapeutic areas:
- Essential Tremor
- Parkinson’s Disease
- Epilepsy
- Dystonia
- Intractable Pain
- Other functional neurological disorders
The investigational, low-frequency (220 kHz) system will not be considered for use in investigator-initiated studies at this moment.
Insightec does not offer financial support. Requests for regulatory sponsorship or clinical operations support will be considered and charged at fair market value. Documentation in support of institutional submissions (ie: cross reference letters) will be considered upon execution of a research agreement.
If you would like additional information about the submission process or to discuss your research idea, please contact Insightec’s medical science team at msl@insightec.com.
In an investigator-initiated study, it is important that the investigator and institution are prepared to take on the role of sponsor. In connection with a commitment of collaboration, all sponsor-investigators must fulfill and agree to the following requirements:
- Submit an investigational device exemption application (or the equivalent) to the competent authorities and ensure that any reviewing authorities are promptly informed of significant new information about an investigation and submit required reports
- select qualified investigators and provide them with the information needed to conduct the investigation properly
- enter into the necessary agreements with investigators
- ensure proper monitoring of the investigation
- ensure that IRB/EC review and approval are obtained
- ensure that the requirements for obtaining informed consent are met
- control and supervise use of the investigational device
- agree to safety reporting to health authorities and to Insightec
- have expert statistical support as appropriate for the study
- deliver written updates and reports to Insightec based on agreed timelines
- submit results of the study for publication in a scientific journal
Additionally, Insightec requires that the following documents are in place before the support can be initiated:
- a fully executed investigator-initiated study support agreement between the sponsor and Insightec
- a fully executed safety data exchange agreement between the sponsor and Insightec
- an EC/IRB and/or health authority approval
- an active service agreement
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