NCT03951324 (VLE-IOV) is a clinical trial of Interobserver agreement or Interrater agreement in Biliary Stricture, sponsored by Innovative Digestive Health Education and Research Inc.

Who is sponsoring NCT03951324?

NCT03951324 is sponsored by Innovative Digestive Health Education and Research Inc.

What drugs are being tested in NCT03951324?

Interventions in NCT03951324: Interobserver agreement or Interrater agreement.

What condition does NCT03951324 study?

NCT03951324 studies Biliary Stricture, Pancreas Cancer, Cholangiocarcinoma, Bile Duct Cancer, Bile Duct Neoplasms Malignant, Bile Duct Neoplasms, Bile Duct Lesions, Bile Duct Obstruction, Bile Duct Diseases, Bile Duct Obstruction, Extrahepatic, Bile Duct Stenosi, Bile Duct Adenoma, Pancreatic Duct Stricture, Pancreatic Duct Stenosis, Pancreatic Duct Obstruction, Pancreatic Ductal Adenocarcinoma, Primary Sclerosing Cholangitis.

Is NCT03951324 still recruiting?

NCT03951324 is currently status unknown. Last updated 12 August 2019.

Last reviewed 2019-08-12 · How we verify

NCT03951324: VLE-IOV

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study

Status unknown Last updated 12 August 2019

What this trial tests

trial testing Interobserver agreement or Interrater agreement in Biliary Stricture in 40 participants. Status unknown.

Timeline

10 May 2019

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Innovative Digestive Health Education and Research Inc
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	40
Start date	10 May 2019
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

Interobserver agreement or Interrater agreement

Conditions studied

Biliary Stricture — all drugs for Biliary Stricture →
Pancreas Cancer — all drugs for Pancreas Cancer →
Cholangiocarcinoma — all drugs for Cholangiocarcinoma →
Bile Duct Cancer — all drugs for Bile Duct Cancer →

Sponsor

Innovative Digestive Health Education and Research Inc

Who can join

18 and older, any sex, with Biliary Stricture or Pancreas Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria. This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study.
Tyberg A, Raijman I, Gaidhane M, Trindade AJ, et al · · 2022 · cited 3× · PMID 35979031 · DOI 10.1055/a-1779-5027

Verify or expand the search:

Other recruiting trials for Biliary Stricture

Currently open trials in the same condition.

NCT06277531 — Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE) · recruiting
NCT06964425 — Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma - a Pilot Study · NA · recruiting
NCT03977779 — Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancrea · NA · recruiting
NCT05210322 — Percutaneous Cholangiopancreatoscopy Registry · active not recruiting
NCT05761483 — Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03951324 (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 Innovative Digestive Health Education and Research Inc
Last refreshed: 12 August 2019

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/NCT03951324.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing