NCT04625673

OsciPulse Device for the Prevention of VTE

Phase 2, Randomized Study of the Tolerability and Safety of the OsciPulse Device for the Prevention of VTE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2 safety and tolerability trial that will take place in two parts. Part one of the trial will determine the tolerability of the OsciPulse device on healthy subjects who wear the device for up to three hours. Healthy volunteers will answer questionnaires and may undergo an ultrasound test at the end of their participation in the trial. Part two of the trial will determine the safety and tolerability of the OsciPulse device on subjects admitted to Penn Presbyterian Medical Center. Eligible subjects will be enrolled for 6 hours. In the first 3 hours, subjects will wear the standard of care intermittent pneumatic compression device or the OsciPulse device. In the second 3 hours, the subject's device will be switched and subjects will wear the alternate device not used in the first 3 hours. Subjects will answer questionnaires and may undergo an ultrasound at the end of the first 3 hours and at the end of the second 3 hours (at hour 6).

Conditions

• Venous Thromboembolism
• Deep Vein Thrombosis
• Pulmonary Thromboembolisms

Interventions

Type	Name	Description
DEVICE	OsciPulse	OsciPulse device and standard IPC device

Timeline

• Start date: 2021-05-12
• Primary completion: 2022-10-15
• Completion: 2022-10-15
• First posted: 2020-11-12
• Last updated: 2023-11-28
• Results posted: 2023-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study