Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Stenosis | — | UNRESOLVED | — |
| Bile Duct Stones | — | UNRESOLVED | — |
| Biliary Stenosis | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DSOC EyeMAX 11Fr | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients scheduled for cholangioscopy
- description
- 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.
- interventionNames
- Device: DSOC EyeMAX 11Fr
Primary outcomes (2)
- measure
- overall satisfaction with the EyeMAX 11Fr DSOC
- timeFrame
- At the end of the procedure
- description
- evaluated using a VAS (ranging from 0 - not at all satisfied - to 10 - extremely satisfied)
- measure
- overall satisfaction with the EyeMAX 11Fr DSOC
- timeFrame
- At the end of the procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKarsenti 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. Ther Adv Gastroenterol. 2025 Aug 12;18:17562848251360117. doi: 10.1177/17562848251360117. eCollection 2025. PMID 40808865