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NCT05046990: MOTIVATION
Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori
trial testing Regular Arrangement of Collecting Venules in Helicobacter Pylori Infection in 1,000 participants. Status unknown.
30 June 2023
Quick facts
| Lead sponsor | Hospital Clinic of Barcelona |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 December 2021 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 September 2023 |
| Sites | 5 locations across Belgium, Germany, Spain |
Drugs / interventions tested
- Regular Arrangement of Collecting Venules
Conditions studied
- Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →
Sponsor
Hospital Clinic of Barcelona
Who can join
18 and older, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC) for the exclusion of Helicobacter pylori (Hp) infection using white light high definition (HD) endoscopy without any kind of zoom or magnification. Gold standard will be mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs). Participants will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases. Secondary objectives are: * To assess whether age, sex and PPIs, have an influence on the results of RAC. * To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC. * To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence. Primary and secondary variables The primary study variable is: \- Endoscopic detection of RAC. Secondary variables will be considered: * Sex * Age * PPI intake in the last two weeks * Centre * Country * Hp prevalence * Endoscopist * Type of endoscope * Significant findings (need of histological confirmation) * Atrophic gastritis * Intestinal metaplasia * Erosive gastritis * Benign gastric ulcer * Gastric adenoma * Gastric cancer
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Regular arrangement of collecting venules as a predictor of <i>Helicobacter pylori</i> absence using white-light endoscopy: a multicenter prospective study outside Asia.
Garcés-Duran R, Llach J, Delgado-Guillena P, Vasapolli R, et al · · 2025 · PMID 41321746 · DOI 10.1177/26317745251387183
Verify or expand the search:
- PubMed search for NCT05046990
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05046990 (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 Hospital Clinic of Barcelona
- Last refreshed: 1 March 2023
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/NCT05046990.
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