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OsciPulse Device for the Prevention of VTE

Primary Purpose

Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Thromboembolisms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

OsciPulse

About this trial

This is an interventional other trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Penn Presbyterian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

Group A will wear the OsciPulse device for the first 24 hours then switch to the standard IPC device for the second 24 hours.

Group B will wear the standard IPC device for the first 24 hours then switch to the OsciPulse device for the second 24 hours.

Outcomes

Primary Outcome Measures

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 visual acuity scale measured in millimeters.

Part 1 - safety assessment through collection of adverse events and targeted physical assessment

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.

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. The subject's response will be recorded on a linear visual acuity scale measured in millimeters.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04625673

First Posted

October 27, 2020

Last Updated

November 2, 2022

Sponsor

University of Pennsylvania

Collaborators

OsciFlex LLC

1. Study Identification

Unique Protocol Identification Number

NCT04625673

Brief Title

OsciPulse Device for the Prevention of VTE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

May 12, 2021 (Actual)

Primary Completion Date

October 15, 2022 (Actual)

Study Completion Date

October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

OsciFlex LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Thromboembolisms

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Group A will wear the OsciPulse device for the first 24 hours then switch to the standard IPC device for the second 24 hours.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Group B will wear the standard IPC device for the first 24 hours then switch to the OsciPulse device for the second 24 hours.

Intervention Type

Device

Intervention Name(s)

OsciPulse

Other Intervention Name(s)

Standard IPC device

Intervention Description

OsciPulse device and standard IPC device

Primary Outcome Measure Information:

Title

Part 1 - Subject's response to tolerability questionnaire

Description

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.

Time Frame

up to 3 hours

Title

Part 1 - safety assessment through collection of adverse events and targeted physical assessment

Description

Time Frame

up to 3 hours

Title

Part 2 - Subject's response to tolerability questionnaire

Description

Time Frame

6 hours

Title

Part 2 - safety assessment through collection of adverse events.

Description

Safety will be assessed by collecting all adverse events while the subject is wearing the device.

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Cuker, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn Presbyterian Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

OsciPulse Device for the Prevention of VTE

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