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

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.

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).

Study Overview

• Status: Completed
• Conditions: Cholangiocarcinoma; Bile Duct Stones; Biliary Stenosis; Bile Duct Stenosis
• Intervention / Treatment: Device: DSOC EyeMAX 11Fr

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• France
  • Charenton-le-Pont, France, 94220
    • Clinique Paris-Bercy
  • Essey-les-Nancy, France, 54270
    • Louis Pasteur Clinic
  • Lyon, France, 69008
    • Jean Mermoz Private Hospital
  • Nantes, France, 44300
    • Jules Verne Clinic
  • Saint Laurent du Var, France, 06700
    • Arnaud Tzang Institut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of introduction of the EyeMAX 11Fr into the duodenoscope's working channel	Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)	At the end of the procedure
Satisfaction of the exit of the device from the working channel	Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)	At the end of the procedure
Satisfaction of the biliary cannulation through the papilla	Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)	At the end of the procedure
Satisfaction of the progression through the bile duct	Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)	At the end of the procedure
Satisfaction of the maneuverability	Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)	At the end of the procedure
Satisfaction of the ease of introducing the biopsy forceps to the target	Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)	At the end of the procedure
Satisfaction of the ease of performing biopsies	Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)	At the end of the procedure
image quality (definition, lens cleaning quality, and brightness)	assessed using a VAS (ranging from 0 - very poor - to 10 - exceptional)	At the end of the procedure
Utility of use of the harness model compared with the model fixed directly on the duodenoscope	evaluated by the question: "Does the harness facilitate handling? (Y/N)"	At the end of the procedure
total ERCP duration	described in minutes	At the end of the procedure
Total cholangioscopy duration	described in minutes	At the end of the procedure
Cholangioscopy success rate	Percentage of patients in whom the procedure was performed with effective bile duct visualization	At the end of the procedure
Number of biopsies performed	Number of bile duct biopsies performed during DSOC procedure	At the end of the procedure
Time required to perform biliary biopsies using DSOC	Described in minutes	At the end of the procedure
Malignant or benign status of the biliary stricture	The diagnosis of cholangiocarcinoma was established through biliary cytopathological examination of biopsies obtained during DSOC , biliary brushing, EUS-FNB, or surgical resection, and/or based on tumor progression observed after more than 6 months of follow-up in cases where specimens were negative for malignancy	After more than 6 months of follow-up in cases where specimens were negative for malignancy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects (AEs) and severe AEs due to ERCP	Defined and graded according to the AGREE classification	Within one month of the procedure

Collaborators and Investigators

• Sponsor: Clinique Paris-Bercy
• Investigators: Study Chair: David Karsenti, MD, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: cholangioscopy; Digital Single-Operator Cholangioscope
• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Constriction, Pathologic; Cholangiocarcinoma
• Other Study ID Numbers: EyeMAX-CREGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

At this time, no decision has been made regarding the sharing of individual participant data (IPD).

This study is the first French experience with the EyeMAX™ 11Fr digital single-operator cholangioscope and has been designed as an observational study. Accordingly, IPD sharing is not currently planned as part of the initial protocol, but may be considered at a later stage.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No