OsciPulse Device for the Prevention of VTE

NCT ID: NCT04625673

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2022-10-15

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).

Conditions

Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Thromboembolisms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours.

Group Type: ACTIVE_COMPARATOR

OsciPulse

Intervention Type: DEVICE

OsciPulse device and standard IPC device

Group B

Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours.

Group Type: ACTIVE_COMPARATOR

OsciPulse

Intervention Type: DEVICE

OsciPulse device and standard IPC device

Interventions

OsciPulse

OsciPulse device and standard IPC device

Intervention Type: DEVICE

Other Intervention Names

Standard IPC device

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:

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

2. Subjects anticipated to require surgical intervention within six (6) hours of admission

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

4. Previous vascular surgery

5. Pregnancy or within 6 weeks of postpartum period

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

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

8. A head-unit is unavailable for the 6 hours or more

9. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OsciFlex LLC

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Cuker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OSC-VTE-001

Identifier Type: OTHER

Identifier Source: secondary_id

844294

Identifier Type: -

Identifier Source: org_study_id