OsciPulse Device for the Prevention of VTE

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04625673
• Collaborator: OsciFlex LLC (Industry)
• Enrollment: 19
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.7
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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 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 the Neuro-ICU and Trauma Surgical ICUs at Penn Presbyterian Medical Center. Eligible subjects will be enrolled for 48 hours. In the first 24 hours, subjects will wear the standard of care intermittent pneumatic compression device or the OsciPulse device. In the second 24 hours subject's device will be switched and subjects will wear the alternate device not used in the first 24 hours. Subjects will answer questionnaires and undergo an ultrasound at the end of the first 24 hours and at the end of the second 24 hours (at hour 48).

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Thromboembolisms	Device: OsciPulse	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Two part, open-label, randomized, crossover study. Part 1 will enroll 3 healthy subjects. Part two will enroll up to 16 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.Two part, open-label, randomized, crossover study. Part 1 will enroll 3 healthy subjects. Part two will enroll up to 16 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)
• Primary Purpose: Other
• Official Title: Phase 2, Randomized Study of the Tolerability and Safety of the OsciPulse Device for the Prevention of VTE
• Actual Study Start Date: May 12, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Group A will wear the OsciPulse device for the first 24 hours then switch to the standard IPC device for the second 24 hours.	Device: OsciPulse; OsciPulse device and standard IPC device; Other Names: Standard IPC device
Active Comparator: Group B Group B will wear the standard IPC device for the first 24 hours then switch to the OsciPulse device for the second 24 hours.	Device: OsciPulse; OsciPulse device and standard IPC device; Other Names: Standard IPC device

Outcome Measures

Primary Outcome Measures

1. Part 1 - Subject's response to tolerability questionnaire [up to 3 hours]

   Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. This will be measured on a linear visual acuity scale measured in millimeters

2. Part 1 - safety assessment through collection of adverse events and targeted physical assessment [up to 3 hours]

   Safety will be assessed by collecting all adverse events while subject is wearing the device. The targeted physical assessment will assess any skin changes detected at the site where the device is applied on the subject.

3. Part 2 - Subject's response to tolerability questionnaire [48 hours]

   Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. The subject's response will be recorded on a linear visual acuity scale measured in millimeters

4. Part 2 - safety assessment through collection of adverse events and targeted physical assessment [48 hours]

   Safety will be assessed by collecting all adverse events while the subject is wearing the device. The targeted physical assessment will assess skin changes detected at the site where the device is applied on the subject.

Secondary Outcome Measures

1. Hemodynamic impact as measured by center line flow velocity in cm/s. [48 hours]

   Ultrasonic measurement of the subject's center line flow within valve sinus. The subject's center line flow will be measured while wearing each device and be compared.

2. Hemodynamic impact as measured by center line flow in mL/mL [48 hours]

   Ultrasonic measurement of the subjects center line flow within the valve sinus will be measured while wearing each device and be compared..

3. Hemodynamic impact as measured by valve sinus forward flow in mL/mL [48 hours]

   Ultrasonic measurement of the subjects valve sinus forward flow will be measured while wearing each device and measurements will be compared.

4. Hemodynamic impact as measured by valve sinus reversing flow in mL/mL [48 hours]

   Ultrasonic measurement of the subjects valve sinus reversing flow will be measured while wearing each device and be compared.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 48 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:

1. 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

1. Subjects anticipated to require surgical intervention within forty-eight (48) hours of admission

2. Subjects with history of VTE (DVT or PE)

3. Previous vascular surgery

4. Pregnancy or within 6 weeks of postpartum period

5. Limitation of life support, life expectancy < 7 days or palliative care

6. Admitted to an outside hospital more than 24 hours prior to screening

7. A head-unit is unavailable for the 24 hours or more

8. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• OsciFlex LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04625673
• Other Study ID Numbers: 844294; OSC-VTE-001
• First Posted: Nov 12, 2020
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pulmonary Embolism; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis

Study Results

No Results Posted as of Apr 14, 2022