Bile Duct StonesCLEVERNCT06974695
Identification of Predictive Factors for Failure of Cholangioscopy-assisted Lithotripsy in the Management of Complex Bile Duct Stones: a Retrospective Study
An observational study of Bile Duct Stones, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study aims to optimize the management of complex biliary stones by identifying predictive factors for SpyGlass lithotripsy failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Stones
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2025to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025
Who may be able to join
- Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025
Who cannot join
- Patient who objected to the collection of their data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marion SCHAEFER, hospital practitioner contact
France1 site, 1 recruiting
- Recruiting
CHRU Brabois Vandoeuvre les Nancy
Vandœuvre-lès-Nancy, Lorraine, 54500
Marion SCHAEFER, Hospital practionner, m.schaefer@chru-nancy.fr
Raphaël Bouchès, Resident
About this study
Official title: Predictive Factors for Cholangioscopy-Assisted Lithotripsy Failure in the Management of Complex Biliary Stones: A Retrospective Analysis
This study aims to optimize the management of complex biliary stones by identifying predictive factors for SpyGlass lithotripsy failure.
- Conditions
- Bile Duct Stones
- Keywords
- Cholangioscopy, Spyglass, Failure, Complex bile duct stone, predictive factor, electrohydraulic lithotripsy, EHL, lithotripsy, ERCP
- Medical subject headings
- Cholecystolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive factors for failure of cholangioscopy lithotripsy in the management of complex bile duct stone
Cholangioscopy-guided lithotripsy failure: defined as stone clearance requiring more than one lithotripsy session or surgical intervention
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 May 2025
- Primary completion1 Jun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct StonesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion SCHAEFER, Central Hospital, Nancy, France
- Investigators
- Marion SCHAEFER, hospital practitioner, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974695
- Sponsor's protocol ID
- 2025_PI_011
- Acronym
- CLEVER
- Status last verified
- Apr 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Cholangioscopy-Assisted Lithotripsy Failure in the Management of Complex Biliary Stones: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06974695
- Acronym / sponsor ID
- CLEVER / 2025_PI_011
- Conditions
- Bile Duct Stones
- Keywords
- Cholangioscopy, Spyglass, Failure, Complex bile duct stone, predictive factor, electrohydraulic lithotripsy, EHL, lithotripsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to optimize the management of complex biliary stones by identifying predictive factors for SpyGlass lithotripsy failure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025
Key inclusion criteria (1 listed)
- Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025
Key exclusion criteria (1 listed)
- Patient who objected to the collection of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive factors for failure of cholangioscopy lithotripsy in the management of complex bile duct stone
Time frame: Baseline
Cholangioscopy-guided lithotripsy failure: defined as stone clearance requiring more than one lithotripsy session or surgical intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marion SCHAEFER, hospital practitioner contact
Marion SCHAEFER, hospital practitioner study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Stones, run by Central Hospital, Nancy, France at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion SCHAEFER, hospital practitioner (m.schaefer@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive factors for failure of cholangioscopy lithotripsy in the management of complex bile duct stone (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.