Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-11-30
2022-06-30
Brief Summary
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Detailed Description
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Subjects will receive CirvoTM compression therapy according to the standard of care protocol at NYU during or after surgery and 18 hours per day for 14 days.
1. Baseline: Following consent, participants will provide demographic, medical history and information with respect to their elective orthopedic procedure and receive training on the CirvoTM device. Participants will be randomized to either digital engagement or no digital engagement groups.
2. Post procedure: After the procedure, CirvoTM device operation will be reviewed with the participant.
3. Discharge: Any adverse events occurring during hospitalization will be reviewed, data capture on the CirvoTM app will be confirmed.
4. 14- day visit: Participants will complete a patient satisfaction questionnaire, provide information with respect to any adverse events including specific details about DVT and readmission and return the devices.
5. 30-day phone call/visit: Participants will be contacted at 30 days to answer questions about DVT's and readmissions.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Cirvo Device
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.
Change in User interfaces of Cirvo compression device application.
Comparison of 2 versions of the Circo user interface
Change in Satisfaction in use of Cirvo device
Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare)
ActiveCare DVT
A commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care.
Change in User interfaces of Cirvo compression device application.
Comparison of 2 versions of the Circo user interface
Change in Satisfaction in use of Cirvo device
Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare)
Interventions
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Change in User interfaces of Cirvo compression device application.
Comparison of 2 versions of the Circo user interface
Change in Satisfaction in use of Cirvo device
Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare)
Eligibility Criteria
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Inclusion Criteria
* Undergoing elective primary total hip/knee replacement
* Planned discharge to home
* Able to train to and operate the Cirvo device with app
Exclusion Criteria
* 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)
18 Years
99 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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James Slover, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Other Identifiers
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19-01399
Identifier Type: -
Identifier Source: org_study_id