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NCT04465682
Dip Home-Based Dipstick Analyzer Performance Evaluation
NA trial testing Experimental: Dip Home-Based Dipstick Analyzer in Urine Detectable Acute and Chronic Diseases in 250 participants. Completed in 30 June 2018.
30 June 2018
Quick facts
| Lead sponsor | Healthy.io Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 250 |
| Start date | 5 April 2018 |
| Primary completion | 30 June 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Experimental: Dip Home-Based Dipstick Analyzer
Conditions studied
- Urine Detectable Acute and Chronic Diseases — all drugs for Urine Detectable Acute and Chronic Diseases →
Sponsor
Healthy.io Ltd.
Who can join
Adults 18 to 80, any sex, with Urine Detectable Acute and Chronic Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
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 NCT04465682
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Healthy.io Ltd. trials
Trials by the same sponsor.
- NCT05838872 — Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands · NA · completed
- NCT04626271 — Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands · NA · completed
- NCT04371159 — A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System · NA · completed
- NCT04466501 — ACR | LAB Urine Analysis Test System Evaluation of Performance · NA · completed
- NCT04466774 — A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyze · NA · completed
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 NCT04465682 (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 Healthy.io Ltd.
- Last refreshed: 10 July 2020
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/NCT04465682.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing