Radial Medical - GAPS

NCT04163913 | Withdrawn DMC

• 1 other identifier: 19-01399
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will prospectively compare compliance rates between a novel FDA cleared wearable compression therapy with and without digital engagement for DVT prophylaxis in both hospital and home environments after total knee or hip arthroplasty.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in compliance using Cirvo compression therapy

  A sample size of 100 subjects is powered at 90% to show a difference of 10% in compliance between the 2 digital engagement cohorts. For each subject, Compliance will be calculated for each participant during the course of therapy in terms of the number of hours of actual use/number of hours of prescribed use. The number of hours will be summarized as days of use for each group. The means of each group will be presented. The primary endpoint is the difference in compliance between the group assigned to digital engagement versus no digital engagement with the Cirvo app. The mean difference will be compared to zero using the paired t-test

  14 day visit (+7 days)

Secondary Outcomes (3)

• Change in patient satisfaction using Cirvo compression therapy

  14 day visit (+7 days)

• Change in staff satisfaction using Cirvo compression therapy.

  14 day visit (+7 days)

• Change in patients satisfaction using Cirvo compression therapy

  30 day visit

Study Arms (2)

Cirvo Device

EXPERIMENTAL

The CirvoTM device (Figure 1) is a lightweight, mobile, active, intermittent leg compression device placed on the calf of the leg, using hook and loop (e.g. Velcro) straps in the similar manner as commercially available intermittent leg compression devices The system utilizes an electro-mechanical drive system to intermittently compress the calf from the ankle toward the knee for a duration and compression level prescribed by the physician. The level of compression delivered by the CirvoTM therapy will be in the same range as existing devices which corresponds to the type of pressure applied by a blood pressure cuff.

Other: Change in User interfaces of Cirvo compression device application.; Other: Change in Satisfaction in use of Cirvo device

ActiveCare DVT

ACTIVE COMPARATOR

A commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care.

Other: Change in User interfaces of Cirvo compression device application.; Other: Change in Satisfaction in use of Cirvo device

Interventions

Change in User interfaces of Cirvo compression device application. OTHER

Comparison of 2 versions of the Circo user interface

ActiveCare DVT; Cirvo Device

Change in Satisfaction in use of Cirvo device OTHER

Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare)

ActiveCare DVT; Cirvo Device

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female over the age of 18
• Undergoing elective primary total hip/knee replacement
• Planned discharge to home
• Able to train to and operate the Cirvo device with app

You may not qualify if:

• History of Pulmonary Embolism
• Active cancer
• BMI \>40
• Current smoker
• History of a hyper-coaguable condition
• Actual or expected prolonged bedrest for \>3 days
• Calf geometry on which Cirvo device does not appropriately fit (prospective cohort only)
• Known sensitivity to any of the materials used in the Cirvo device (prospective cohort only)
• Currently participating or planning to participate in any other investigational clinical evaluation during study period that may, in the opinion of the investigator, affect compliance (prospective cohort only)

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• James Slover, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 15, 2019
• Study Start: November 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2022
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.