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

NCT06933576 | Completed FDA Device

• 1 other identifier: EyeMAX-CREGG
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

cholangioscopy; Digital Single-Operator Cholangioscope

Outcome Measures

Primary Outcomes (2)

• overall satisfaction with the EyeMAX 11Fr DSOC

  evaluated using a VAS (ranging from 0 - not at all satisfied - to 10 - extremely satisfied)

  At the end of the procedure

• overall satisfaction with the EyeMAX 11Fr DSOC

  Satisfaction with the EyeMAX 11Fr DSOC compared with the device currently available in France, the SpyGlass™ DS II DSOC. Satisfaction was categorized as better, equivalent, or worse relative to the SpyGlass™ DS II.

  At the end of the procedure

Secondary Outcomes (15)

• Satisfaction of introduction of the EyeMAX 11Fr into the duodenoscope's working channel

  At the end of the procedure

• Satisfaction of the exit of the device from the working channel

  At the end of the procedure

• Satisfaction of the biliary cannulation through the papilla

  At the end of the procedure

• Satisfaction of the progression through the bile duct

  At the end of the procedure

• Satisfaction of the maneuverability

  At the end of the procedure

Other Outcomes (1)

• Adverse effects (AEs) and severe AEs due to ERCP

  Within one month of the procedure

Study Arms (1)

Patients scheduled for cholangioscopy

All patients who underwent digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China) and were admitted to one of the CREGG centers between February 2024 and January 2025.

Device: DSOC EyeMAX 11Fr

Interventions

DSOC EyeMAX 11Fr DEVICE

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

Patients scheduled for cholangioscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included all consecutive patients who were referred to one of the participating expert tertiary endoscopy units (5 centers from the CREGG - French Society of Private Hepato-Gastroenterology, in which the EyeMAX DSOC systems were made available), during the first year of availability of this device in France

You may qualify if:

• all consecutive patients who were referred to one of the participating expert tertiary endoscopy units for an ERCP for a bile duct stenosis

You may not qualify if:

• patients with significant tissue mass that could easily be punctured by EUS-FNB were not included.
• non-accessibility to the bile duct due to a history of Billroth II or Roux-en-Y reconstruction,
• coagulation disorders (such as partial thromboplastin time \> 42 seconds, prothrombin time \[Quick value\] \< 50%, or platelet count \< 50,000/mm³), or treatment with clopidogrel.

Sponsors & Collaborators

• Clinique Paris-Bercy: lead

Study Sites (5)

Clinique Paris-Bercy

Charenton-le-Pont, 94220, France

Location

Louis Pasteur Clinic

Essey-lès-Nancy, 54270, France

Location

Jean Mermoz Private Hospital

Lyon, 69008, France

Location

Jules Verne Clinic

Nantes, 44300, France

Location

Arnaud Tzang Institut

Saint-Laurent-du-Var, 06700, France

Location

Related Publications (1)

• Karsenti D, Sportes A, Leblanc S, Bechet S, Derman J, Fassler I, Brieau B. 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. Therap Adv Gastroenterol. 2025 Aug 12;18:17562848251360117. doi: 10.1177/17562848251360117. eCollection 2025.

  PMID: 40808865 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma; Cholecystolithiasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• David Karsenti, MD

  Pôle Digestif Paris-Bercy, Clinique Paris-Bercy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 18, 2025
• Study Start: February 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

FR (5)