Clinical trial NCT05087108: Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow
Official title: A Crossover Study of the Hemodynamic Effect of the OsciPulse Device Compared to Reference Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Venous Thromboses
Venous Stasis
Keywords: Venous compression
Intermittent pneumatic compression
Lead sponsor: OsciFlex LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-10-21
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation sites. Once the imaging valve is identified the baseline level of venous flow will be collected in 30 s video clips of 2D color Doppler videos and spectral Doppler. Next, either the OsciPulse device, or one of the two reference therapy devices, will be applied by study personnel according to the device's specific instructions. The subject will wear the device during the capture of 1 spectral Doppler clip and three 30 s 2D color Doppler ultrasound clips on both the left and right leg. Next, the remaining two devices will be applied based on instructions, and vascular ultrasound clips captured for each. Completion of this visit protocol will be the end of the study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device or reference therapies.
* Severe peripheral artery or venous disease.

Primary outcomes:
measure: Venous valve sinus forward flow volume index
timeFrame: Visit 1 - 60 minutes
measure: Venous valve sinus reversing flow volume index
timeFrame: Visit 1 - 60 minutes
measure: Deep vein centerline flow
timeFrame: Visit 1 - 60 minutes
measure: Venous valve sinus rouleaux
timeFrame: Visit 1 - 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: OsciFlex LLC
name: John Welsh, PhD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Chandra Sehgal, PhD
role: PRINCIPAL_INVESTIGATOR
References: