N/A
Completed N=15
Clinical Evaluation of the CM-1500 During Hemodialysis
Source: ClinicalTrials.gov NCT05125848 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Average Relative Index Value Following a Hemodialysis Procedure — 93.05 Relative Index (RI)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Relative Index Value Following a Hemodialysis Procedure |
93.05 | — |
| SECONDARY Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions |
2.27 | — |
| SECONDARY Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions |
2.91 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05125848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.