A Crossover Study of the Hemodynamic Effect of the OsciPulse Device Compared to Reference Therapies

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular compression devices. Our hypothesis is that the OsciPulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: t
View:

• Adult age ≥40 years old

• Generally healthy.

• No history of diagnosed vascular disease including: DVT, PE, VTE, peripheral vascular disease, post-phlebitic syndrome, or chronic venous insufficiency.

• Mentally alert and understand English proficiently.

• Able to give informed consent.

Locations
United States
Pennsylvania
University of Pennsylvania
Philadelphia
Time Frame
Start Date: 2022-03-17
Completion Date: 2022-06-30
Participants
Target number of participants: 16
Treatments
Experimental: Study arm
In this single arm study all enrolled subjects will the intervention by the investigational device, and both reference devices. Ultrasound will be used to measure the blood flow in the subject during the use of all three devices.
Authors
Chandra Sehgal
Sponsors
Leads: OsciFlex LLC
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania

This content was sourced from clinicaltrials.gov