Last reviewed · How we verify
NCT05852184
Hb Scope: A Multi-Center Validation Trial
trial testing Hb Scope APP in Hemoglobin in 504 participants. Completed in 31 January 2024.
31 January 2024
Quick facts
| Lead sponsor | China Medical University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 504 |
| Start date | 1 July 2023 |
| Primary completion | 31 January 2024 |
| Estimated completion | 31 January 2024 |
| Sites | 3 locations across Taiwan, United Arab Emirates |
Drugs / interventions tested
- Hb Scope APP
Conditions studied
- Hemoglobin — all drugs for Hemoglobin →
- Hemodialysis — all drugs for Hemodialysis →
Sponsor
China Medical University Hospital
Who can join
Adults 20 to 90, any sex, with Hemoglobin or Hemodialysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The global prevalence of end-stage renal disease (ESRD) was estimated ranging 5.3 to 9.7 million patients in 2017 and is a major healthcare cost driver in both developed and developing economies. The majority of patients with ESRD, approximately 90%, received in-center maintenance hemodialysis (HD). Although HD patients are under the close supervision of a nephrologist, they are vulnerable to anemia and substantial hemoglobin (Hb) variability, which are controversially associated with poor clinical outcomes, such as all-cause mortality. The contemporary narrow target hemoglobin level recommended in the KDIGO and KDOQI guidelines, despite the ongoing debates, poses a crucial challenge in maintaining the optimal hemoglobin level in HD patients. The Big Data Center at China Medical University Hospital (CMUH) has developed a tool, Hb Scope APP, that can use the color of the HD tubing to predict real-time Hb levels by leveraging the smartphone's camera capacity and machine learning (ML) technology. The performance of the Hb Scope ML algorithm in predicting Hb \> 10 g/dL can reach an accuracy of 0.93 and an AUROC of 0.99 in the testing dataset. This opens an opportunity to establish a vibrant digital ecosystem for automatic anemia management. Innovative ML tools must be appropriately regulated before these algorithms are adopted into clinical practice. Therefore, in the current validation study, we propose to do a multicenter validation trial for validating whether the Hb predicted by Hb Scope APP can achieve an area under the receiver operating curve (AUROC) of at least 0.80 in the adult HD populations from CMUH, Asia University Hospital (AUH) in Taiwan, and SEHA Kidney Care (SKC)-Central in the United Arab Emirates.
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 NCT05852184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hemoglobin
Currently open trials in the same condition.
- NCT06857630 — Preoperative Hemoglobin and Acute Kidney Injury in Emergency Surgery · recruiting
- NCT06608862 — The Impact of Hormonal Contraceptive Use and Lifestyle Factors on Fracture Risk and Bone Quality in Young Female Adults · recruiting
- NCT04526678 — Oslo Footballplayers Iron Supplementation and Training (FIT) Study · NA · active not recruiting
Other China Medical University Hospital trials
Trials by the same sponsor.
- NCT07525700 — The Effects of Combining Electronic Picture Books With RPG-Based Gamified Learning on Nursing Students' Motivation and L · NA · not yet recruiting
- NCT07463391 — Chinese Classics Recitation Training in Subjective Cognitive Decline · NA · not yet recruiting
- NCT07482189 — Effectiveness and Efficiency of an Upper Limb Active-Passive Exoskeleton Robot in Patients With Frozen Shoulder · NA · not yet recruiting
- NCT07437144 — Exploring the Effects of Shangshou Daoyin Method on Improving Sleep Quality, Quality of Life, and TCM Constitution in Br · NA · not yet recruiting
- NCT07232667 — Digital Technology for Active and Healthy Ageing in Taiwan · NA · not yet recruiting
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 NCT05852184 (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 China Medical University Hospital
- Last refreshed: 14 July 2025
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/NCT05852184.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing