NCT05389488

OsciPulse D-dimer Efficacy Trial

A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OsciFlex LLC · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	OsciPulse system	The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.
DEVICE	Flowtron ACS900	The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.

Timeline

• Start date: 2022-12-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2022-05-25
• Last updated: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study