EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis (NCT07620080) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis
120 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 1\. Lithiasic biliary obstruction
* 2\. Patients younger than 18 years
* 3\. ASA 4 or ASA 5 patients
* 4\. Pregnant or breastfeeding women
* 5\. Coagulation disorders preventing biopsy procedures
* 6\. Surgical anatomy preventing papillary access
* 7\. Patients unable to provide informed consent
* 8\. Upper gastrointestinal obstruction
* 9\. Intolerance to endoscopy
* 10\. Severe cardiopulmonary disease
* 11\. Acute pancreatitis or severe cholangitis
* 12\. Severe contrast agent allergy
* 13\. Patients under legal protection measures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
Timeframe: Through study completion, an average of 1 year