Dialysis Clinical Trial
Official title:
Clinical Evaluation of the CM-1500 During Hemodialysis
Verified date | May 2022 |
Source | Zynex Monitoring Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 4, 2022 |
Est. primary completion date | March 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ability to provide written informed consent - Ability and willingness to comply with the study procedures and duration requirements, including connection of the device to the left wrist/hand and maintaining relatively motionless during the session - 18 years of age or older - Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment. Exclusion Criteria: - Females who are pregnant or breastfeeding - Undergone an amputation of the left upper extremity - Subjects with left arm hemodialysis access only - Diagnosed with dextrocardia - Subjects who have a pacemaker - Subjects who have any other underlying condition that would inhibit completion of participation in the study, per Investigator opinion |
Country | Name | City | State |
---|---|---|---|
United States | DaVita Clinical Research | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Zynex Monitoring Solutions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterize changes in the Relative Index During a Hemodialysis Procedure | The primary objective of the study is to characterize changes in the CM-1500 Relative Index over the duration of a hemodialysis procedure | 1-6 hours | |
Secondary | Characterize the intersubject and intrasubject variability in Relative Index changes across multiple hemodialysis sessions | The secondary objective of the study is to characterize the intersubject and intrasubject variability in Relative Index changes across the three hemodialysis sessions | 1-2 weeks |
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