Venous ThrombosesPhase 2NCT05389488
OsciPulse D-dimer Efficacy Trial
A Phase 2 study testing OsciPulse system and Flowtron ACS900 in people with Venous Thromboses and Ischemic Stroke, run by OsciFlex LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Venous Thromboses, Ischemic Stroke
- What is being tested?
- OsciPulse system and Flowtron ACS900
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2022to Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged ≥ 18 years old
- Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
- Last known normal < 24 hours.
- NIH stroke score ≥5
- Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
- Prescribed mechanical therapy for DVT prophylaxis.
Who cannot join
- 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
Show all 15Show fewer
- Amputated foot or leg on one or two sides
- Compartment syndrome
- Severe lower extremity edema
- Acute deep vein thrombosis
- Subjects who received tPA therapy for their stroke
- Pregnancy or within 6 weeks of postpartum period
- Limitation of life support, life expectancy < 7 days, or in hospice care
- A head-unit is unavailable for the first 24 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19146
About this study
Official title: A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the OsciPulse System. During the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.
- Conditions
- Venous Thromboses, Ischemic Stroke
- Being tested
- OsciPulse system, Flowtron ACS900
- Medical subject headings
- Venous Thrombosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsciPulse systemDevice
The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.
Flowtron ACS900Device
The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space. Receives: Device: Flowtron ACS900 |
| Study Arm | Experimental | Subjects will receive compression therapy from the OsciPulse system. Receives: Device: OsciPulse system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in serum d-dimer levels
We will measure the change in serum d-dimer levels over time as a marker of venous coagulation.
Measured: 7 days
Secondary outcomes (1)
Device tolerability
We will measure the number of patients that are compliant with the treatment and quantify their experience with a questionnaire.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Change in funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- OsciFlex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389488
- Sponsor's protocol ID
- OSC-VTE-003
- Status last verified
- Nov 2023
- First submitted
- 20 May 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
- ClinicalTrials.gov ID
- NCT05389488
- Acronym / sponsor ID
- OSC-VTE-003
- Conditions
- Venous Thromboses, Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OsciFlex LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the OsciPulse System. During the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Device: Flowtron ACS900Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space. |
| Study Arm | Experimental | Device: OsciPulse systemSubjects will receive compression therapy from the OsciPulse system. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult aged ≥ 18 years old
- Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
- Last known normal < 24 hours.
- NIH stroke score ≥5
- Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
Key exclusion criteria (15 listed)
- Inability or contraindication to applying IPC to both legs such as:
- Subjects who received tPA therapy for their stroke
- Pregnancy or within 6 weeks of postpartum period
- Limitation of life support, life expectancy < 7 days, or in hospice care
- A head-unit is unavailable for the first 24 hours or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsciPulse systemThe OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow. | Device | Study Arm |
| Flowtron ACS900The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow. | Device | Control Arm |
Primary outcome
Relative change in serum d-dimer levels
Time frame: 7 days
We will measure the change in serum d-dimer levels over time as a marker of venous coagulation.
1 secondary outcome
Device tolerability
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OsciPulse system and Flowtron ACS900 in people with Venous Thromboses and Ischemic Stroke, run by OsciFlex LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in serum d-dimer levels (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.