Last reviewed · How we verify

NCT01846195

Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw

Completed NA Results posted Last updated 9 November 2022
What this trial tests

NA trial testing CM 1500 in Blood Loss in 50 participants. Completed in 20 March 2013.

Timeline
6 June 2012
Primary endpoint
20 March 2013
20 March 2013

Quick facts

Lead sponsorZynex Monitoring Solutions
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment50
Start date6 June 2012
Primary completion20 March 2013
Estimated completion20 March 2013
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Zynex Monitoring Solutions

Who can join

Adults 18 to 35, 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.

Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw Primary · At study completion (completion of blood draw)

Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw

GroupValue95% CI
no Blood Draw0
Blood Draw45

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected through the completion of the study. Adverse events per subject may have occurred during the blood draw or within 24 hours following with any potential reaction to electrode adhesive.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

no Blood Draw
Serious: 0/5 (0%)
Deaths: 0/5
Blood Draw
Serious: 0/45 (0%)
Deaths: 0/45
Other adverse events (1 terms — click to expand)

ReactionSystemno Blood DrawBlood Draw
Vasovagal Reaction to Blood DrawGeneral disorders

Data from ClinicalTrials.gov NCT01846195 adverse events section.

Sponsor's own description

Non-invasive monitoring to measure changes in blood volume.

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 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/NCT01846195.

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