N/A N=23 Randomized Other

OsciPulse Device for the Prevention of VTE

Venous Thromboembolism · Deep Vein Thrombosis · Pulmonary Thromboembolisms

Bottom Line

View on ClinicalTrials.gov: NCT04625673 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

Nov 2023

Primary outcome: Primary: Part 1 - Subject's Response to Tolerability Questionnaire — 3; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: OsciPulse (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1 - Subject's Response to Tolerability Questionnaire	3; 0; 0; 0; 0; 0	—
PRIMARY Part 1 - Safety Assessment Through Collection of Adverse Events	0; 0; 0	—
PRIMARY Part 2 - Subject's Response to Tolerability Questionnaire	7.2; 6.08; 6.8; 9.03; 7; 4.47	—
PRIMARY Part 2 - Safety Assessment Through Collection of Adverse Events.	9; 10; 9; 10; 0; 0	—

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).

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:

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
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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04625673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.