CompletedNot Applicable

OsciPulse Device for the Prevention of VTE

United States23 participantsStarted 2021-05-12

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Inability or contraindication to applying IPC to both legs such as:
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1 - Subject's Response to Tolerability Questionnaire

Timeframe: up to 3 hours

Part 1 - Safety Assessment Through Collection of Adverse Events

Timeframe: up to 3 hours

Part 2 - Subject's Response to Tolerability Questionnaire

Timeframe: 6 hours

Part 2 - Safety Assessment Through Collection of Adverse Events.

Timeframe: 6 hours

Trial details

NCT IDNCT04625673

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-15

Results submitted2023-06-01

View on ClinicalTrials.gov More Venous Thromboembolism trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Inability or contraindication to applying IPC to both legs such as:
. 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

What they're measuring

Part 1 - Subject's Response to Tolerability Questionnaire

Timeframe: up to 3 hours

Part 1 - Safety Assessment Through Collection of Adverse Events

Timeframe: up to 3 hours

Part 2 - Subject's Response to Tolerability Questionnaire

Timeframe: 6 hours

Part 2 - Safety Assessment Through Collection of Adverse Events.

Timeframe: 6 hours