Initial Case Series With Exalt Single-Use Duodenoscope

Boston Scientific

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Device: Exalt Model D Single-Use Duodenoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT03701958

E7145

Details and patient eligibility

About

To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Exalt DScope 01

Other group

Description:

Subjects will have a clinically indicated per standard of care ERCP procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.

Treatment:

Device: Exalt Model D Single-Use Duodenoscope