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NCT04285775
A Novel Device for Surveillance of Vascular Access Sites for Bleeding
trial testing Application of device which monitors for bleeding - Blood Warning Technology with Continuous Hemoglobin sensor (BWATCH) in Dialysis; Complications in 250 participants. Completed in 30 June 2020.
30 June 2020
Quick facts
| Lead sponsor | Changi General Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 1 March 2019 |
| Primary completion | 30 June 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Application of device which monitors for bleeding - Blood Warning Technology with Continuous Hemoglobin sensor (BWATCH)
Conditions studied
- Dialysis; Complications — all drugs for Dialysis; Complications →
- Wound Complication — all drugs for Wound Complication →
- Catheter Complications — all drugs for Catheter Complications →
- Hemorrhage — all drugs for Hemorrhage →
Sponsor
Changi General Hospital
Who can join
21 and older, any sex, with Dialysis; Complications or Wound Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background Bleeding is often encountered after vascular access procedures for dialysis and fatal episodes of haemorrhage has been reported. A technological solution was sought to monitor for such rare but potentially catastrophic incidents. A novel device, BWATCH, was developed to detect fresh blood from wounds. Aims The aim of this clinical trial was to evaluate the sensitivity and specificity of the device in detecting bleeding in a clinical environment. Methods This a prospective, observational study on inpatients who will have a dialysis catheter inserted or removed. The device will be placed over the dressing for at least 6 hours. An alarm will be triggered if the device detects moisture and wavelength of light reflected specific for haemoglobin.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A device for surveillance of vascular access sites for bleeding: results from a clinical evaluation trial.
Chionh CY, Soh DY, Tan CH, Khaw JY, et al · · 2020 · cited 1× · PMID 33097747 · DOI 10.1038/s41598-020-74571-2
Verify or expand the search:
- PubMed search for NCT04285775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Changi General Hospital trials
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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 NCT04285775 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Changi General Hospital
- Last refreshed: 28 January 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/NCT04285775.
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