Last reviewed · How we verify
NCT04251013: BIB
Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy
NA trial testing Biliary brushing with the RX Cytology brush, Boston Scientific in Biliary Stricture in 51 participants. Completed in 1 March 2022.
1 March 2022
Quick facts
| Lead sponsor | Société Française d'Endoscopie Digestive |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 51 |
| Start date | 1 July 2020 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 March 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Biliary brushing with the RX Cytology brush, Boston Scientific
- Biliary brushing with the Infinity® brush, US Endoscopy
Conditions studied
- Biliary Stricture — all drugs for Biliary Stricture →
- Jaundice, Obstructive — all drugs for Jaundice, Obstructive →
Sponsor
Société Française d'Endoscopie Digestive — full company profile →
Who can join
Adults 18 to 90, any sex, with Biliary Stricture or Jaundice, Obstructive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years
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 NCT04251013
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Biliary Stricture
Currently open trials in the same condition.
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- NCT05210322 — Percutaneous Cholangiopancreatoscopy Registry · active not recruiting
- NCT05761483 — Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. · recruiting
Other Société Française d'Endoscopie Digestive trials
Trials by the same sponsor.
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- NCT06535490 — Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions · not yet recruiting
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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 NCT04251013 (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 Société Française d'Endoscopie Digestive
- Last refreshed: 21 June 2022
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/NCT04251013.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing