An interventional study of DSC and ERC in Biliary Stones, sponsored by Boston Scientific Corporation. Completed at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangiography (ERC).
The objective of this study is to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangioscopy (ERC).
88 studies on the registry are indexed under Cholecystolithiasis; 17 are open to participants now.
This study's enrollment of 250 is above the median of 100 across 59 interventional studies indexed under Cholecystolithiasis.
Browse Cholecystolithiasis studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-complex biliary stone disease, defined as 5 or fewer stones in the common bile or common hepatic duct with largest stone no larger than 10 mm in size. If stones not seen on imaging (US, CT) the bile duct diameter should be ≤12 mm*
* Given the poor sensitivity (approximately 20%) for biliary stones of CT and US, the diameter of the dilated CBD is used as a surrogate for largest stone diameter
Availability of non-invasive imaging to determine the diameter of the bile duct and number and size of bile duct stones if visible on imaging
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After screening examination and confirmed presence of non-complex bile duct stone by image, patients will be randomly assigned by stratified randomization to Endoscopic Retrograde Cholangioscopy (ERC) treatment.
Device: ERC
After screening examination and confirmed presence of non-complex bile duct stone by imagine, patients will be randomly assigned by stratified randomization to fluoroscopy/radiation-free direct solitary cholangioscopy (DSC).
Device: DSC
Stone removal without fluoroscopy using the SpyGlass device.
Also known as: Direct Solitary Cholangioscopy
Standard of care stone removal with fluoroscopy.
Also known as: Endoscopic Retrograde Cholangiography
Number of Participants With Complete Stone Clearance
Prospectively compare DSC vs. ERC
Time frame: 30 Days
Rate of Serious Adverse Events
To evaluate all SAEs including death, severity, onset, time to resolution.
Time frame: 30 Days
Radiation Exposure
Total Fluoroscopy time
Time frame: 3 hours
Duration of Procedure
Defined as time from duodenoscope in to completion of stone clearance.
Time frame: 3 hours
| Milestone | ERC Arm | DSC Arm |
|---|---|---|
| Started | 126 | 124 |
| Completed | 115 | 117 |
| Not completed | 11 | 7 |
Prospectively compare DSC vs. ERC
| Participants | ERC Arm | DSC Arm |
|---|---|---|
| Number of Participants With Complete Stone Clearance | 112 | 108 |
To evaluate all SAEs including death, severity, onset, time to resolution.
| Participants | ERC Arm | DSC Arm |
|---|---|---|
| Rate of Serious Adverse Events | 5 | 7 |
Total Fluoroscopy time
| seconds | ERC Arm | DSC Arm |
|---|---|---|
| Radiation Exposure | 133 (0 to 720) | 0 (0 to 454) |
Defined as time from duodenoscope in to completion of stone clearance.
| minutes | ERC Arm | DSC Arm |
|---|---|---|
| Duration of Procedure | 11.9 (3.8 to 137.9) | 22.1 (6.0 to 67.0) |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ERC Arm | 1/126 (0.8%) | 5/126 (4%) | 0/126 (0%) |
| DSC Arm | 1/124 (0.8%) | 7/124 (5.6%) | 0/124 (0%) |
| Event | ERC Arm | DSC Arm |
|---|---|---|
| PancreatitisGastrointestinal disorders | 3/126 | 5/124 |
| Duodenal injuryInjury, poisoning and procedural complications | 0/126 | 1/124 |
| Gastrointestinal bleedGastrointestinal disorders | 1/126 | 1/124 |
| Abdominal painGastrointestinal disorders | 1/126 | 0/124 |
| DiarrheaGastrointestinal disorders | 1/126 | 0/124 |
| Age, Continuous(years) | ERC Arm | DSC Arm | Total |
|---|---|---|---|
| Mean | 53.6 ± 16.7 | 50.3 ± 18 | 52 ± 17.4 |
| Sex: Female, Male(Participants) | ERC Arm | DSC Arm | Total |
|---|---|---|---|
| Female | 71 | 79 | 150 |
| Male | 55 | 45 | 100 |
| Race and Ethnicity Not Collected(Participants) | ERC Arm | DSC Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | ERC Arm | DSC Arm | Total |
|---|---|---|---|
| United States | 40 | 39 | 79 |
| Italy | 0 | 1 | 1 |
| Thailand | 27 | 26 | 53 |
| India | 59 | 58 | 117 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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