Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 4

Conditions: Bile Duct Carcinoma; Bile Duct Adenocarcinoma

Treatments: Device: Dragonfly™ Digital Pancreaticobiliary System

Study type: Interventional

Funder types: Other

Identifiers

NCT07120295

DGFLY-CLIN-2023-01 (Other Identifier)

23-2548.cc

Details and patient eligibility

About

This study plans to enroll up to 75 research subject who have a biliary disorder such as bile duct stones or intermediate biliary strictures. The purpose of this research is to assess whether the Dragonfly™ Pancreaticobiliary Scope functioned as intended in combination with the commercially available accessories during your scheduled endoscopy procedure. This includes achieving stone fragmentation of difficult biliary stone(s) while obtaining adequate tissue specimens for analysis. There will also be a Product performance evaluation as rated by the endoscopist operating the DPS System and evaluation of ergonomics and usability.

Enrollment: 75 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision to sign and date the consent form;

2. Adult patients ≥ 21 years old;

3. Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:

   1. Indeterminate biliary stricture, or
   2. Failed biliary stone extraction with conventional techniques.

4. Willing and able to follow study procedures and comply with study follow-up.

Exclusion criteria

1. Pregnancy or lactation;
2. Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
3. Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
4. Coagulopathy (INR > 1.8) or thrombocytopenia (Platelets < 50,000) that is not correctable and felt to be a contraindication to proceeding with biopsy or lithotripsy per the treating endoscopist;
5. Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
6. Patients who are not candidates for anesthesia to permit ERCP.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Interventional Group

Experimental group

Treatment:

Device: Dragonfly™ Digital Pancreaticobiliary System