NCT04625673

OsciPulse Device for the Prevention of VTE

Completed NA Results posted Last updated 28 November 2023

What this trial tests

NA trial testing OsciPulse in Venous Thromboembolism in 23 participants. Completed in 15 October 2022.

Timeline

12 May 2021

Primary endpoint
15 October 2022

15 October 2022

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	23
Start date	12 May 2021
Primary completion	15 October 2022
Estimated completion	15 October 2022
Sites	1 location across United States

Drugs / interventions tested

• OsciPulse

Conditions studied

• Venous Thromboembolism — all drugs for Venous Thromboembolism →
• Deep Vein Thrombosis — all drugs for Deep Vein Thrombosis →
• Pulmonary Thromboembolisms — all drugs for Pulmonary Thromboembolisms →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Venous Thromboembolism or Deep Vein Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1 - Subject's Response to Tolerability Questionnaire Primary · 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 sco

Group	Value	95% CI
Part 1, Healthy Subjects	3
Part 2, Group A, OsciPulse, Then Standard IPC	0
Part 2, Group B, Standard IPC, Then OsciPulse	0
Part 1, Healthy Subjects	0
Part 2, Group A, OsciPulse, Then Standard IPC	0
Part 2, Group B, Standard IPC, Then OsciPulse	0
Part 1, Healthy Subjects	0
Part 2, Group A, OsciPulse, Then Standard IPC	0
Part 2, Group B, Standard IPC, Then OsciPulse	0

Part 1 - Safety Assessment Through Collection of Adverse Events Primary · 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."

Group	Value	95% CI
Part 1, Healthy Subjects	0
Part 2, Group A, OsciPulse, Then Standard IPC	0
Part 2, Group B, Standard IPC, Then OsciPulse	0

Part 2 - Subject's Response to Tolerability Questionnaire Primary · 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). F

Comfort-OsciPulse

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	7.2	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	6.08	0 – 10

Comfort-Standard IPC

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	6.8	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	9.03	0 – 10

Disruption-OsciPulse

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	7	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	4.47	0 – 10

Disruption-Standard IPC

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	7.48	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	8.18	0 – 10

Noise-OsciPulse

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	3.48	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	4.08	0 – 10

Noise-Standard IPC

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	7.6	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	7.05	0 – 10

Movement Interference-OsciPulse

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	5.6	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	7.15	0 – 10

Movement Interference-Standard IPC

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	4.78	0 – 10
Part 2, Group B, Standard IPC, Then OsciPulse	6.7	0 – 10

Part 2 - Safety Assessment Through Collection of Adverse Events. Primary · 6 hours

Safety will be assessed by collecting all adverse events while the subject is wearing the device.

No AEs-OsciPulse

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	9
Part 2, Group B, Standard IPC, Then OsciPulse	10

No AEs-Standard IPC

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	9
Part 2, Group B, Standard IPC, Then OsciPulse	10

AEs-OsciPulse

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	0
Part 2, Group B, Standard IPC, Then OsciPulse	0

AEs-Standard IPC

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	0
Part 2, Group B, Standard IPC, Then OsciPulse	0

AEs-not related to device

Group	Value	95% CI
Part 2, Group A, OsciPulse, Then Standard IPC	0
Part 2, Group B, Standard IPC, Then OsciPulse	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Healthy Subjects

Serious: 0/3 (0%)

Deaths: 0/3

OsciPulse

Serious: 0/20 (0%)

Deaths: 0/20

Standard IPC

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	Part 1: Healthy Subjects	OsciPulse	Standard IPC
Pancreatitis	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Pancreatitis.

Data from ClinicalTrials.gov NCT04625673 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.