a long flexible tube with a camera on the tip duodenoscope
Conditions
Interventions
Subjects will have their clinically indicated ERCP or other duodenoscope-based
procedure performed using the Exalt single-use duodenoscope.
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study 3. Scheduled for a clinically indicated ERCP
Exclusion criteria
Exclusion criteria: 1. Potentially vulnerable subjects, including, but not limited to pregnant women 2. Subjects for whom endoscopic techniques are contraindicated 3. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor 4. Investigator discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the trial is the ability to complete the ERCP or other duodenoscope-based procedures for the intended indication(s). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be recorded as secondary endpoints during index procedure through follow-up: 1. Document endoscopist rating of the Exalt single-use duodenoscope compared to marketed reusable duodenoscopes as it pertains to various design and performance related attributes. 2. Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope. 3. Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope-based procedure. | — |
Countries
Netherlands
Outcome results
None listed