Health Condition 1: K00-K95- Diseases of the digestive system
Conditions
Interventions
Intervention1: ERCP or other duodenoscope based procedure completed with EXALT Model D Duodenoscope.: A duodenoscope will be guided through the mouth, esophagus, stomach to the duodenum. Accessories a
Sponsors
Boston Scientific Corporation
Eligibility
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 or other duodenoscope-based procedure
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 |
|---|---|
| Ability to complete the ERCP or other duodenoscope-based procedure for the intended indication(s)Timepoint: Ability to complete the procedure is assessed at the end of the procedure on study day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Document endoscopist rating of the Exalt single-use duodenoscope compared to marketed reusable duodenoscopes as it pertains to various design and performance related attributesTimepoint: Assessed at the end of the procedure on study day 1;Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or duodenoscope-based procedureTimepoint: Assessed on study day 30;Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscopeTimepoint: Assessed at the end of the procedure on study day 1 | — |
Countries
Canada, France, Germany, Hong Kong, India, Italy, Netherlands, United States of America
Contacts
Public ContactD Nageshwar Reddy
Asian Institute of Gastroenterology
Outcome results
None listed