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| ID | Type | Description | Link |
|---|---|---|---|
| OSC-VTE-001 | Other Identifier | University of Pennsylvania |
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| Name | Class |
|---|---|
| OsciFlex LLC | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours. |
|
| Group B | Active Comparator | Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsciPulse | Device | OsciPulse device and standard IPC device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 - Subject's Response to Tolerability Questionnaire | 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 score. | up to 3 hours |
| Part 1 - Safety Assessment Through Collection of Adverse Events | 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." | up to 3 hours |
| Part 2 - Subject's Response to Tolerability Questionnaire | 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. | 6 hours |
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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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Cuker, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: OsciPulse in Healthy Subjects | Testing OsciPulse device in healthy subjects. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1, OsciPulse in Healthy Subjects | Part 1 subjects only |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1 - Subject's Response to Tolerability Questionnaire | 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 score. | This outcome measure is applicable to part 1 only. | Posted | Count of Participants | Participants | up to 3 hours |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Healthy Subjects | OsciPulse in Healthy Subjects | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Lead | University of Pennsylvania | 215.573.7101 | psom-ind-ide@pobox.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2022 | Jun 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Two part, open-label, randomized, crossover study. Part 1 will enroll 3 healthy subjects. Part two will enroll 15-20 in-patient subjects. Part two will have two arms.
Arm A will wear the OsciPulse then wear the standard IPC device. Arm B will wear the standard IPC device then wear the OsciPulse device.
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| Part 2 - Safety Assessment Through Collection of Adverse Events. |
Safety will be assessed by collecting all adverse events while the subject is wearing the device. |
| 6 hours |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | 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. |
| OG002 | 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. |
|
|
| Primary | Part 1 - Safety Assessment Through Collection of Adverse Events | 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." | This outcome measure is applicable to part 1 only. | Posted | Count of Participants | Participants | up to 3 hours |
|
|
|
| Primary | Part 2 - Subject's Response to Tolerability Questionnaire | 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. | This outcome measure is applicable to part 2 only, which had groups A and B. | Posted | Mean | Full Range | score on a scale | 6 hours |
|
|
|
| Primary | Part 2 - Safety Assessment Through Collection of Adverse Events. | Safety will be assessed by collecting all adverse events while the subject is wearing the device. | 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. | Posted | Count of Participants | Participants | 6 hours |
|
|
|
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | OsciPulse | Those wearing the OsciPulse device. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Standard IPC | Those wearing the standard IPC device. | 0 | 20 | 1 | 20 | 0 | 20 |
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| D013927 |
| Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| Disruption-OsciPulse |
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| Disruption-Standard IPC |
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| Noise-OsciPulse |
|
| Noise-Standard IPC |
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| Movement Interference-OsciPulse |
|
| Movement Interference-Standard IPC |
|
| AEs-OsciPulse |
|
| AEs-Standard IPC |
|
| AEs-not related to device |
|