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Investigator Initiated Research Program
Welcome to Vapotherm’s Investigator Initiated Research (IIR) Program.
As part of our commitment to improve patient lives, we are dedicated to supporting independent clinical research involving Vapotherm High Velocity Nasal Insufflation (HVNI) and other devices in the Vapotherm family. We are interested in collaborating with physicians and scientists committed to advancing respiratory care through research.
If you have a research question or hypothesis involving HVNI or another product that you wish to evaluate, please contact [email protected]. You will be notified by email of the acceptance or denial of the project within 2 weeks.
IIR Qualifications:
IIR submissions will be reviewed with the following in mind:
- Scientific merit
- Alignment with Vapotherm’s areas of research interest
- Availability of resources
Areas of Interest:
- Thermoregulation
- Expanded treatment areas and patient populations
- Ambulation
- Rehabilitation
- Expanded use in critical care
- Cardiovascular
- Exercise
- Long-term HFNC use
- Home use
- Trauma
- Economic
FAQ’s
How long does the application review process take?
The review process will be complete within 2 weeks.
What if my IIR request is denied?
All decisions are final, although anyone is welcome to reapply at any time. You will be notified of the reason for denial.
If my IIR request is approved, will I receive a contract template?
Yes.
Will the study need approval from an independent ethics committee?
The PI is responsible for the study and all regulatory requirements including oversight by an IRB. If a study investigator needs IRB assistance, this can be addressed on a case-by-case basis.
What is the role of an Investigator?
- To implement and oversee the management of the day-to-day conduct of the clinical investigation as well as ensuring data integrity and the rights, safety, and well-being of the subjects involved in the clinical investigation, all while using Good Clinical Practice (GCP).
- Design the protocol and conduct the scientific investigation.
- Gain approval through Institutional Review Board (IRB).
- Control study protocol and manage the data generated during the study.
- Notify the company of significant study milestones as required in the study agreement.
- Provide a draft manuscript and study data upon completion of the study.
- Report safety data to regulatory authorities, and the IRB.
- Understand and comply with all requirements of institution(s) which are associated, or where research will occur.
Do you provide products if requested for IIR study?
Yes – machines are loaned for the duration of the trial. Disposables are given for the duration of the trial.
Will any financial assistance be provided if needed?
No financial compensation will be provided as these are not sponsored studies. No administrative overhead will be provided. Registration costs for Investigators who are presenting data may be provided.
CAUTION: US Federal law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at https://vapotherm.com/resources/support/precision-flow-reference/. For spontaneously breathing patients. High Velocity Therapy (HVT) does not provide total ventilatory requirements of the patient. It is not a ventilator. Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case, including escalation of care depending on patient condition.