Global Prospective Case Series Using a Single-Use Duodenoscope

Overview

About this study

The purpose of this study is to confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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 or other duodenoscope-based procedure.

Exclusion Criteria:

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Bret Petersen, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Bret Petersen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials