NCT07620080Not yet recruiting
EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis
Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps. The EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures. The primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 19 May 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2029
- Lead sponsor
- David KARSENTI
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07620080
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Sept 2026 to the primary completion date, Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 6\. Surgical anatomy preventing papillary access
Other illness
- 5\. Coagulation disorders preventing biopsy procedures
- 10\. Severe cardiopulmonary disease
- 12\. Severe contrast agent allergy
Age
- 2\. Patients younger than 18 years
Other
- 1\. Lithiasic biliary obstruction
- 3\. ASA 4 or ASA 5 patients
- 4\. Pregnant or breastfeeding women
- 7\. Patients unable to provide informed consent
- 8\. Upper gastrointestinal obstruction
- 9\. Intolerance to endoscopy
- 11\. Acute pancreatitis or severe cholangitis
- 13\. Patients under legal protection measures
Who the study is looking for
- 1\. Adult patients aged 18 to 84 years
- 2\. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture
- 3\. Absence of a mass easily accessible to EUS-guided fine needle aspiration
- 4\. ASA physical status 1-3
- 5\. No participation in another clinical trial
- 6\. Written informed consent obtained
- 7\. Patient affiliated with a social security system or equivalent
Age in the registry: 18 years to 84 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.