OsciPulse Device for the Prevention of VTE

November 27, 2023 updated by: University of Pennsylvania

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

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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 3 hours then switch to the OsciPulse device for the second 3 hours.
OsciPulse device and standard IPC device
Other Names:
  • Standard IPC device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 - Subject's Response to Tolerability Questionnaire
Time Frame: 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 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
Time Frame: up to 3 hours

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
Time Frame: 6 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 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.
Time Frame: 6 hours
Safety will be assessed by collecting all adverse events while the subject is wearing the device.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Adam Cuker, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 844294
  • OSC-VTE-001 (Other Identifier: University of Pennsylvania)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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