NCT06933576Completed
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 · Last updated 18 Apr 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 28 (actual)
- First submitted
- 10 Apr 2025
- Start date
- 1 Feb 2024
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- Clinique Paris-Bercy
- NCT number
- NCT06933576
What you commit to
- Study type: Observational
- Participants enrolled: 28
- From 1 Feb 2024 to the primary completion date, 30 Jan 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- non-accessibility to the bile duct due to a history of Billroth II or Roux-en-Y reconstruction,
Lab values
- coagulation disorders (such as partial thromboplastin time \> 42 seconds, prothrombin time \[Quick value\] \< 50%, or platelet count \< 50,000/mm³), or treatment with clopidogrel.
Other
- patients with significant tissue mass that could easily be punctured by EUS-FNB were not included.
Who the study is looking for
- all consecutive patients who were referred to one of the participating expert tertiary endoscopy units for an ERCP for a bile duct stenosis
Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Paris Bercy Coordinator of this site? Confirm its status | Charenton-le-Pont | France | Unknown status |
| Louis Pasteur Clinic Coordinator of this site? Confirm its status | Essey-lès-Nancy | France | Unknown status |
| Jean Mermoz Private Hospital Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Jules Verne Clinic Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Arnaud Tzang Institut Coordinator of this site? Confirm its status | Saint-Laurent-du-Var | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.