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NCT04706221

Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

Completed NA Results posted Last updated 27 March 2024
What this trial tests

NA trial testing CM-1500 in Blood Loss in 200 participants. Completed in 29 November 2021.

Timeline
15 January 2021
Primary endpoint
29 November 2021
29 November 2021

Quick facts

Lead sponsorZynex Monitoring Solutions
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment200
Start date15 January 2021
Primary completion29 November 2021
Estimated completion29 November 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Zynex Monitoring Solutions

Who can join

Adults 18 to 100, any sex, with Blood Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Relative Index Change During PACU Stay Primary · Length of PACU Stay (Range: 46 to 353 minutes)

The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss rel

GroupValue95% CI
Blood Volume Monitoring - Open Surgery-2.01± 4.00
Blood Volume Monitoring - Laparoscopic Surgery-1.32± 3.11

Sponsor's own description

The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of CM-1500

Trials testing the same drug.

Other recruiting trials for Blood Loss

Currently open trials in the same condition.

Other Zynex Monitoring Solutions trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04706221.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing