Last reviewed · How we verify
NCT04778553
Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study
trial testing iMOST X-1 Hematology Analyzer in Hematologic Tests in 60 participants. Completed in 21 January 2021.
9 December 2020
Quick facts
| Lead sponsor | Essenlix Corporation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 19 October 2020 |
| Primary completion | 9 December 2020 |
| Estimated completion | 21 January 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- iMOST X-1 Hematology Analyzer
Conditions studied
- Hematologic Tests — all drugs for Hematologic Tests →
Sponsor
Essenlix Corporation
Who can join
18 and older, any sex, with Hematologic Tests. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.
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:
- PubMed search for NCT04778553
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04778553 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Essenlix Corporation
- Last refreshed: 3 March 2021
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/NCT04778553.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing