NCT06933576

Contribution of the EyeMAX™ 11Fr (Micro-Tech) Digital Single-Operator Cholangioscope With a Wide Working Channel

Contribution of the EyeMAX™ 11Fr (Micro-Tech) Digital Single-Operator Cholangioscope With a Wide Working Channel: A Multicenter Pilot Study on the First French Experiences.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Clinique Paris-Bercy · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Background and aims Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel. A new DSOC (EyeMAXTM 11Fr, Micro-Tech Endoscopy, Nanjing, China) with a 2.0 mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the initial French experience. Methods A retrospective multicenter observational study on DSOC was conducted across five endoscopy units within the CREGG (French Society of Private Hepato-Gastroenterology). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the SpyglassTM DS II DSOC (Boston Scientific).

Conditions

• Cholangiocarcinoma
• Biliary Stenosis
• Bile Duct Stones
• Bile Duct Stenosis

Interventions

Type	Name	Description
DEVICE	DSOC EyeMAX 11Fr	digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China)

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2025-04-18
• Last updated: 2025-04-18

Locations

5 sites across 1 country: France

Regulatory

• FDA-regulated device study