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

Conditions

• Bile Duct Adenocarcinoma
• Bile Duct Carcinoma

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dragonfly™ Digital Pancreaticobiliary System — DEVICE
  Dragonfly™ Digital Pancreaticobiliary System is indicated for use in the direct visualization of the biliary and pancreatic ducts for diagnostic and therapeutic interventions during endoscopic procedures. DPS is a single-use device that serves as an access and delivery catheter used with a proprietary DDC. The DDC is intended to control auto-illumination, and process images from the DPS for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

Study Details

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.

Key Dates

Start date

Aug 11, 2025

Status verified

Aug 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Interventional Group

Primary Outcome Measure

Stone Fragmentation- Clearing of Biliary Stones [ Time Frame: Up to 6 months ]

Central Contacts

• Rodolfo Hernandez
  303-724-1870
  [email protected]

Locations (1)

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