OsciPulse Device for the Prevention of VTE

Study Overview
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Brief Summary
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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).

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

Conditions
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Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Thromboembolisms

Intervention / Treatment
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* Device: OsciPulse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part 1: Adult over the age of 40, generally healthy without a current foot or ankle injury, no history of diagnosed vascular disease including DVT, PE, VTE, post-phlebetic syndrome, or chronic venous insufficiency, mentally alert and understand English proficiently, able to give informed consent Part 2: Adult over the age of 18, admitted to the at Penn Presbyterian Medical Center, anticipated decreased level of mobility for at least 6 hours as determined by the clinical team in collaboration with study personnel, mentally alert and understand English proficiently, able to give informed consent. Exclusion Criteria: Part 1: injury to the lower limbs, skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device. Part 2: Inability or contraindication to applying IPC to both legs such as: Evidence of bone fracture in lower extremities Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, & ischemic limb in the legs at the site of IPC placement Acute ischemia in the lower extremities Severe peripheral vascular disease Amputated foot or leg on one or two sides Compartment syndrome Severe lower extremity edema Subjects anticipated to require surgical intervention within six (6) hours of admission Subjects with history of VTE (DVT or PE) Previous vascular surgery Pregnancy or within 6 weeks of postpartum period Limitation of life support, life expectancy < 7 days or palliative care Admitted to an outside hospital more than 24 hours prior to screening A head-unit is unavailable for the 6 hours or more At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two part, open-label, randomized, crossover study. Part 1 will enroll 3 healthy subjects. Part two will enroll 15-20 in-patient subjects. Part two will have two arms. Arm A will wear the OsciPulse then wear the standard IPC device. Arm B will wear the standard IPC device then wear the OsciPulse device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours. | Device: OsciPulse<br>* OsciPulse device and standard IPC device<br>* Other names: Standard IPC device;|
| Active Comparator: Group B<br>Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours. | Device: OsciPulse<br>* OsciPulse device and standard IPC device<br>* Other names: Standard IPC device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1 - Subject's Response to Tolerability Questionnaire | Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. This will be measured on a linear 100 mm visual acuity scale measured in millimeters. Subjects are provided with the scale and asked to make a mark on the line that corresponds to their experience with the device. The least favorable rating is on the left hand side, the most favorable rating is on the right hand side of the scale. The mark on the line is measured in millimeters, resulting in least favorable scores having a lower score, and most favorable ratings having a higher score. | up to 3 hours | 
| Part 1 - Safety Assessment Through Collection of Adverse Events | Safety will be assessed by collecting & reviewing all adverse events while subject is wearing the device. Subjects will indicate if the device caused 1) no discomfort, 2) mild discomfort, or 3) significant discomfort. To move on to Part 2, all subjects in Part 1 must indicate that there was not significant discomfort. | up to 3 hours | 
| Part 2 - Subject's Response to Tolerability Questionnaire | Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. This will be measured on a linear 100mm visual acuity scale measured in millimeters. Subjects are provided with the scale and asked to make a mark on the line that corresponds to their experience with the device. The minimum (least favorable) rating is on the left hand side and is equal to zero (0), the maximum (most favorable) rating is on the right hand side of the scale and is equal to one hundred (100). For Comfort, scores range from very disruptive (0) to no effect (10). For Disruption, scores range from very disruptive (0) to no effect (10). For Noise, scores range from very loud (0) to not noticeable (10). For Movement, scores range from very restrictive (0) to no effect (10). The mark on the line is measured in millimeters, resulting in minimum (least favorable) scores having a lower score, and maximum (most favorable) ratings having a higher score. | 6 hours | 
| Part 2 - Safety Assessment Through Collection of Adverse Events. | Safety will be assessed by collecting all adverse events while the subject is wearing the device. | 6 hours |