Trial Outcomes & Findings for OsciPulse Device for the Prevention of VTE (NCT NCT04625673)

NCT ID: NCT04625673

Last Updated: 2023-11-28

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

up to 3 hours

Results posted on

2023-11-28

Participant Flow

Part 1 subjects did NOT go on to Part 2. Part 1 were healthy subjects. Part 2 were patients (not healthy subjects). The study protocol describes the 2 separate groups as "part 1" and "part 2" of the study, which is why this terminology was used.

Participant milestones

Participant milestones
Measure	Part 1: OsciPulse in Healthy Subjects Testing OsciPulse device in healthy subjects.	Part 2, Group A, OsciPulse, Then Standard IPC Subjects in Part 2, Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours. Subjects who participated in Part 1 of the study did NOT participate in Part 2.	Part 2, Group B, Standard IPC Device, Then OsciPulse Part 2, Group B subjects will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours. Subjects who participated in Part 1 of the study did NOT participate in Part 2.
Overall Study STARTED	3	9	11
Overall Study COMPLETED	3	9	10
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OsciPulse Device for the Prevention of VTE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1, OsciPulse in Healthy Subjects n=3 Participants Part 1 subjects only	Part 2, Group A, OsciPulse, Then Standard IPC n=9 Participants Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours.	Part 2, Group B, Standard IPC, Then OsciPulse n=11 Participants Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized African American	0 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants	23 participants n=4 Participants

PRIMARY outcome

Timeframe: up to 3 hours

Population: This outcome measure is applicable to part 1 only.

Outcome measures

Outcome measures
Measure	Part 1, Healthy Subjects n=3 Participants Healthy subjects	Part 2, Group A, OsciPulse, Then Standard IPC Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours.	Part 2, Group B, Standard IPC, Then OsciPulse Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours.
Part 1 - Subject's Response to Tolerability Questionnaire Mild discomfort	0 Participants	0 Participants	0 Participants
Part 1 - Subject's Response to Tolerability Questionnaire Significant discomfort	0 Participants	0 Participants	0 Participants
Part 1 - Subject's Response to Tolerability Questionnaire No discomfort	3 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: up to 3 hours

Population: This outcome measure is applicable to part 1 only.

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."

Outcome measures

Outcome measures
Measure	Part 1, Healthy Subjects n=3 Participants Healthy subjects	Part 2, Group A, OsciPulse, Then Standard IPC Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours.	Part 2, Group B, Standard IPC, Then OsciPulse Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours.
Part 1 - Safety Assessment Through Collection of Adverse Events	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: This outcome measure is applicable to part 2 only, which had groups A and B.

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). For Disruption, scores range from "very disruptive" (0) to "no effect" (10). For Noise, scores range from "very loud" (0) to "not noticeable" (10). For Movement, scores range from "very restrictive" (0) to "no effect" (10). The mark on the line is measured in millimeters, resulting in minimum (least favorable) scores having a lower score, and maximum (most favorable) ratings having a higher score.

Outcome measures

Outcome measures
Measure	Part 1, Healthy Subjects n=6 Participants Healthy subjects	Part 2, Group A, OsciPulse, Then Standard IPC n=6 Participants Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours.	Part 2, Group B, Standard IPC, Then OsciPulse Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours.
Part 2 - Subject's Response to Tolerability Questionnaire Comfort-OsciPulse	7.2 score on a scale Interval 0.0 to 10.0	6.08 score on a scale Interval 0.0 to 10.0	—
Part 2 - Subject's Response to Tolerability Questionnaire Comfort-Standard IPC	6.8 score on a scale Interval 0.0 to 10.0	9.03 score on a scale Interval 0.0 to 10.0	—
Part 2 - Subject's Response to Tolerability Questionnaire Disruption-OsciPulse	7 score on a scale Interval 0.0 to 10.0	4.47 score on a scale Interval 0.0 to 10.0	—
Part 2 - Subject's Response to Tolerability Questionnaire Disruption-Standard IPC	7.48 score on a scale Interval 0.0 to 10.0	8.18 score on a scale Interval 0.0 to 10.0	—
Part 2 - Subject's Response to Tolerability Questionnaire Noise-OsciPulse	3.48 score on a scale Interval 0.0 to 10.0	4.08 score on a scale Interval 0.0 to 10.0	—
Part 2 - Subject's Response to Tolerability Questionnaire Noise-Standard IPC	7.6 score on a scale Interval 0.0 to 10.0	7.05 score on a scale Interval 0.0 to 10.0	—
Part 2 - Subject's Response to Tolerability Questionnaire Movement Interference-OsciPulse	5.6 score on a scale Interval 0.0 to 10.0	7.15 score on a scale Interval 0.0 to 10.0	—
Part 2 - Subject's Response to Tolerability Questionnaire Movement Interference-Standard IPC	4.78 score on a scale Interval 0.0 to 10.0	6.7 score on a scale Interval 0.0 to 10.0	—

PRIMARY outcome

Timeframe: 6 hours

Population: This outcome measure is applicable to part 2 only, which had groups A and B. The subject consented to Part 2, Group B had an AE prior to being able to use either device. So subject was consented to study but did not have an AE with either standard or investigational device.

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

Outcome measures

Outcome measures
Measure	Part 1, Healthy Subjects n=9 Participants Healthy subjects	Part 2, Group A, OsciPulse, Then Standard IPC n=11 Participants Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours.	Part 2, Group B, Standard IPC, Then OsciPulse Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours.
Part 2 - Safety Assessment Through Collection of Adverse Events. No AEs-OsciPulse	9 Participants	10 Participants	—
Part 2 - Safety Assessment Through Collection of Adverse Events. No AEs-Standard IPC	9 Participants	10 Participants	—
Part 2 - Safety Assessment Through Collection of Adverse Events. AEs-OsciPulse	0 Participants	0 Participants	—
Part 2 - Safety Assessment Through Collection of Adverse Events. AEs-Standard IPC	0 Participants	0 Participants	—
Part 2 - Safety Assessment Through Collection of Adverse Events. AEs-not related to device	0 Participants	1 Participants	—

Adverse Events

Part 1: Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OsciPulse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard IPC

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Healthy Subjects n=3 participants at risk OsciPulse in Healthy Subjects	OsciPulse n=20 participants at risk Those wearing the OsciPulse device.	Standard IPC n=20 participants at risk Those wearing the standard IPC device.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • 6 hours One subject was removed from study due to SAE before inv. product was administered. This subject is included in the safety assessment only. Subjects who participated in Part 1 did NOT go on to Part 2.	0.00% 0/20 • 6 hours One subject was removed from study due to SAE before inv. product was administered. This subject is included in the safety assessment only. Subjects who participated in Part 1 did NOT go on to Part 2.	5.0% 1/20 • 6 hours One subject was removed from study due to SAE before inv. product was administered. This subject is included in the safety assessment only. Subjects who participated in Part 1 did NOT go on to Part 2.

Other adverse events

Adverse event data not reported

Additional Information

Regulatory Lead

University of Pennsylvania

Phone: 215.573.7101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place