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CholangiocarcinomaEyeMAX-CREGGNCT06933576

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

An observational study of Cholangiocarcinoma and Biliary Stenosis, run by Clinique Paris-Bercy at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
DSOC EyeMAX 11Fr
Type of treatment
Medical device
How many people
28 participants
Where
5 sitesFrance
Study dates
1 Feb 2024to 30 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Clinique Paris-Bercy

    Charenton-le-Pont, 94220

  • Louis Pasteur Clinic

    Essey-lès-Nancy, 54270

  • Jean Mermoz Private Hospital

    Lyon, 69008

  • Jules Verne Clinic

    Nantes, 44300

  • Arnaud Tzang Institut

    Saint-Laurent-du-Var, 06700

Other trials in France

About this study

Official title: 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).

Being tested
DSOC EyeMAX 11Fr
Keywords
cholangioscopy, Digital Single-Operator Cholangioscope
Medical subject headings
Cholangiocarcinoma, Cholecystolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSOC EyeMAX 11FrDevice

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

Study groups in NCT06933576
Study groupRoleWhat they receive
Patients scheduled for cholangioscopyAll 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.
Receives: Device: DSOC EyeMAX 11Fr

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall satisfaction with the EyeMAX 11Fr DSOC

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

    Measured: At the end of the procedure

  2. 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.

    Measured: At the end of the procedure

Secondary outcomes (15)

  1. 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)

    Measured: At the end of the procedure

  2. 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)

    Measured: At the end of the procedure

  3. Satisfaction of the biliary cannulation through the papilla

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

    Measured: At the end of the procedure

  4. Satisfaction of the progression through the bile duct

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

    Measured: At the end of the procedure

  5. Satisfaction of the maneuverability

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

    Measured: At the end of the procedure

  6. 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)

    Measured: At the end of the procedure

  7. Satisfaction of the ease of performing biopsies

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

    Measured: At the end of the procedure

  8. image quality (definition, lens cleaning quality, and brightness)

    assessed using a VAS (ranging from 0 - very poor - to 10 - exceptional)

    Measured: At the end of the procedure

  9. 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)"

    Measured: At the end of the procedure

  10. total ERCP duration

    described in minutes

    Measured: At the end of the procedure

  11. Total cholangioscopy duration

    described in minutes

    Measured: At the end of the procedure

  12. Cholangioscopy success rate

    Percentage of patients in whom the procedure was performed with effective bile duct visualization

    Measured: At the end of the procedure

  13. Number of biopsies performed

    Number of bile duct biopsies performed during DSOC procedure

    Measured: At the end of the procedure

  14. Time required to perform biliary biopsies using DSOC

    Described in minutes

    Measured: At the end of the procedure

  15. 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

    Measured: After more than 6 months of follow-up in cases where specimens were negative for malignancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start1 Feb 2024
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06933576
Sponsor's protocol ID
EyeMAX-CREGG
Acronym
EyeMAX-CREGG
Status last verified
Apr 2025
First submitted
10 Apr 2025
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: 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.

Publications

  • 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. Ther Adv Gastroenterol. 2025 Aug 12;18:17562848251360117. doi: 10.1177/17562848251360117. eCollection 2025.

    PubMed 40808865

Questions about this trial

What is this clinical trial studying?

An observational study of Cholangiocarcinoma and Biliary Stenosis, run by Clinique Paris-Bercy at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall satisfaction with the EyeMAX 11Fr DSOC (time frame: At the end of the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06933576, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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