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

NCT07120295 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Bile Duct Adenocarcinoma
  • Bile Duct Carcinoma

Interventions

DEVICE

Dragonfly™ Digital Pancreaticobiliary System

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.

Sponsors & Collaborators

  • Dragonfly Endoscopy Inc

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120295 on ClinicalTrials.gov