EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis

Sponsor
David KARSENTI
Study ID
NCT07620080
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Biliary Stricture
  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • EYEMAX® cholangioscopy system — DEVICE
    Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the EYEMAX® working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.
  • SPYGLASS™ DS system — DEVICE
    Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS cholangioscopy system (Boston Scientific) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the SPYGLASS™ DS working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.

Study Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).
  • Active Comparator: Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).

Primary Outcome Measure

Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Related Studies