A DCT was designed and conducted in ProofPilot Rx, enrolling 300 patients with Migraine and Tension Headache for digital biomarker exploration, using BYOD. As a true SaaS solution, ProofPilot Rx delivered enormous cost savings, accessibility, and agility.
The Fisher Wallace Stimulator® is a wearable neurostimulation device commercialized by Fisher Wallace Laboratories, Inc. The device had been used & prescribed for decades based on anecdotal feedback for depression, anxiety, and insomnia. When the FDA updated neuromodulation device regulatory guidelines, Fisher Wallace chose ProofPilot to conduct three registration studies.
In just six months using ProofPoilot’s end-to-end platform, with minimal clinical trial staff, Fisher Wallace:
The study results lead to successful FDA clearance of The Fisher Wallace Stimulator® – one PMA for depression and two 510Ks for general anxiety disorder and insomnia.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541563. Source: ClinicalTrials.gov.
Joovv used ProofPilot on several clinical studies, including the investigation of full-body red & near-infrared photobiomodulation therapy for mental health in the winter months. The study was conducted during the winter months in northern latitudes using the Joovv Mini 2.0 Device on self-reported non-clinical mental health, sleep, and energy levels.
In just a few weeks using ProofPoilot’s end-to-end platform, Joovv:
The trial was cost neutral versus many hundreds of thousands of dollars (or even millions) for a typical consumer 510K medical device clinical trial
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251000. Source: ClinicalTrials.gov.
At ProofPilot, you can schedule a consultation and we can take you through a demo. We’ll show you how to practice some easy use cases. Please use your company email address.