OsciPulse Device for the Prevention of VTE

NCT04625673 | Completed Results FDA Device

• 2 other identifiers: 844294OSC-VTE-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Thromboembolisms

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Study Arms (2)

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.

Device: OsciPulse

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.

Device: OsciPulse

Interventions

OsciPulse DEVICE

OsciPulse device and standard IPC device

Also known as: Standard IPC device

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• OsciFlex LLC: collaborator

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Results Point of Contact

• Title: Regulatory Lead
• Organization: University of Pennsylvania

psom-ind-ide@pobox.upenn.edu

215.573.7101

Study Officials

• Adam Cuker, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 12, 2020
• Study Start: May 12, 2021
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-11

Locations

US (1)