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Trial Outcomes & Findings for A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff (NCT NCT03328624)

NCT ID: NCT03328624

Last Updated: 2019-09-06

Results Overview

1. FULL SCALE NAME: Wearability, comfort, and acceptance of the DVT cuff Scale. Created a likert-type scale in RedCAP with values from 0 to 10, with higher score equaling better outcome. 2. TIME FRAME: Each participant wore the DVT cuff under study for 20 minutes, and evaluated their experience using the scale above. Evaluated through User Questionnaire: Recovery Force DVT Cuff - Post-Demonstration Patient Questionnaire; and subject interview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

1 day

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure
DVT Cuff Users
Current or previous DVT cuff users Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff
Overall Study
STARTED
36
Overall Study
COMPLETED
36
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DVT Cuff Users
n=36 Participants
Current or previous DVT cuff users Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
36 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
Race (NIH/OMB)
White
22 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
8 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 day

1. FULL SCALE NAME: Wearability, comfort, and acceptance of the DVT cuff Scale. Created a likert-type scale in RedCAP with values from 0 to 10, with higher score equaling better outcome. 2. TIME FRAME: Each participant wore the DVT cuff under study for 20 minutes, and evaluated their experience using the scale above. Evaluated through User Questionnaire: Recovery Force DVT Cuff - Post-Demonstration Patient Questionnaire; and subject interview

Outcome measures

Outcome measures
Measure
DVT Cuff Users
n=36 Participants
Current or previous DVT cuff users Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff
Comfort and Patient Acceptance
8.89 score on a scale
Standard Deviation 1.77

Adverse Events

DVT Cuff Users

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

SALSA@USC

Phone: 323-442-5528

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place