A Study to Establish Initial Case Series with Exalt 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) 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.

Exclusion Criteria :

Altered pancreaticobiliary anatomy.
Potentially vulnerable subjects, including, but not limited to pregnant women.
Subjects for whom endoscopic techniques are contraindicated.
Subjects 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	Contact
Rochester, Minn. Mayo Clinic principal investigator Bret Petersen, M.D.	Closed for enrollment	Contact information: Amanda Schimek (507)284-3565 Schimek.Amanda@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bret Petersen, M.D.

Closed for enrollment

Contact information:

Amanda Schimek

(507)284-3565

Schimek.Amanda@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials