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Keep this study
Lead
Boston Scientific Corporation
This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 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 7 days after their procedure.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 years or older
Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Scheduled for a clinically indicated ERCP
You may not be if
Altered pancreaticobiliary anatomy
Potentially vulnerable subjects, including, but not limited to pregnant women
Subjects for whom endoscopic techniques are contraindicated
Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
Investigator discretion
Clareo Health | Initial Case Series With Exalt Single-Use Duodenoscope
