An interventional study of Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangiopancreatography, sponsored by Boston Scientific Corporation. Completed at 22 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Other
Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures
This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. Up to 1000 cases will be included at up to 40 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 30 days after their procedure.
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Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
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Exclusion Criteria:
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Device: Exalt Model D Single-Use Duodenoscope
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Number of Participants With Successful ERCP Procedure
The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.
Time frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Endoscopist Rating
Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best)
Time frame: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.
Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.
Time frame: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
Number of Adverse Events (SAEs) Related to the Device and/or the Procedure
Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures
Time frame: SAEs are assessed through 30 days after the procedure.
| Milestone | Exalt DScope 02 |
|---|---|
| Started | 551 |
| Completed | 495 |
| Not completed | 56 |
The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.
| Participants | Exalt DScope 02 |
|---|---|
| Number of Participants With Successful ERCP Procedure | 529 |
Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best)
| Score on a scale | Exalt DScope 02 |
|---|---|
| Endoscopist Rating | 8.0 (1.0 to 10.0) |
The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.
| Participants | Exalt DScope 02 |
|---|---|
| Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope | 37 |
Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures
| Events | Exalt DScope 02 |
|---|---|
| Number of Adverse Events (SAEs) Related to the Device and/or the Procedure | 46 |
Collected over 30 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exalt DScope 02 | 17/551 (3.1%) | 85/551 (15.4%) | 75/551 (13.6%) |
| Event | Exalt DScope 02 |
|---|---|
| PancreatitisGastrointestinal disorders | 19/551 |
| CholangitisHepatobiliary disorders | 6/551 |
| SepsisInfections and infestations | 5/551 |
| Procedural painInjury, poisoning and procedural complications | 5/551 |
| Abdominal painGastrointestinal disorders | 4/551 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 4/551 |
| CholangiocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/551 |
| Disease progressionGeneral disorders | 3/551 |
| PyrexiaGeneral disorders | 3/551 |
| CholecystitisHepatobiliary disorders | 3/551 |
| Event | Exalt DScope 02 |
|---|---|
| Abdominal painGastrointestinal disorders | 25/551 |
| NauseaGastrointestinal disorders | 8/551 |
| PyrexiaGeneral disorders | 5/551 |
| Procedural painInjury, poisoning and procedural complications | 5/551 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 5/551 |
| VomitingGastrointestinal disorders | 4/551 |
| Abdominal discomfortGastrointestinal disorders | 3/551 |
| DiarrhoeaGastrointestinal disorders | 3/551 |
| Procedural nauseaInjury, poisoning and procedural complications | 3/551 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 2/551 |
| Age, Continuous(years) | Exalt DScope 02 |
|---|---|
| Mean | 59.9 ± 15.9 |
| Sex/Gender, Customized(Participants) | Exalt DScope 02 |
|---|---|
| Sex, Male | 281 |
| Sex, Female | 269 |
| Sex, other | 1 |
| Race and Ethnicity Not Collected(Participants) | Exalt DScope 02 |
|---|
| Region of Enrollment(participants) | Exalt DScope 02 |
|---|---|
| Canada | 25 |
| Netherlands | 25 |
| Singapore | 25 |
| Hong Kong | 25 |
| United States | 276 |
| Italy | 25 |
| South Africa | 25 |
| Australia | 25 |
| France | 25 |
| Germany | 25 |
| India | 50 |
| American Society of Anesthesiology physical status(Participants) | Exalt DScope 02 |
|---|---|
| I | 66 |
| II | 198 |
| III | 250 |
| IV | 32 |
| V | 0 |
| Not assessed | 5 |
| Relevant gastrointestinal medical history(participants) | Exalt DScope 02 |
|---|---|
| Bile duct stones/gallstones(current) | 168 |
| Documented biliary or pancreatic stricture, unresolved | 124 |
| Current immunosuppression (any cause) | 71 |
| Chronic pancreatitis | 68 |
| Pancreatic tumor | 63 |
| Abnormal image finding | 60 |
| Cholangitis (current) | 53 |
| Cholangiocarcinoma | 46 |
| Primary sclerosing cholangitis | 24 |
| Other gastrointestinal cancer | 22 |
| Pancreatic stones (current) | 22 |
| Recurrent cholangitis | 21 |
| Hepatic tumor | 18 |
| Hepatitis | 11 |
| Pancreatic pseudocyst | 9 |
| Known history of Multidrug-resistant organisms (MDRO) colonization | 2 |
| Known current MDRO colonization | 2 |
| Current documented bacterial infection, other than cholangitis | 8 |
| Other | 146 |
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