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| ID | Type | Description | Link |
|---|---|---|---|
| DGFLY-CLIN-2023-01 | Other Identifier | Dragonfly Endoscopy, Inc. |
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| Name | Class |
|---|---|
| Dragonfly Endoscopy Inc | UNKNOWN |
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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 Dragonflyâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dragonflyâ„¢ Digital Pancreaticobiliary System | Device | Dragonflyâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Fragmentation- Clearing of Biliary Stones | Will evaluate the effectiveness of digital cholangioscopy (DC) in guiding fragmentation of difficult biliary stones. Will examine the efficacy of the intraductal lithotripsy procedure utilizing electrohydraulic lithotripsy in achieving biliary stone fragmentation and complete bile duct stone clearance among patients who have failed conventional stone extraction techniques. Stone fragmentation and complete ductal clearance will be assessed using descriptive statistics with interquartile range (IQR) for the number of procedures to achieve clearance at index or subsequent procedures. Ninety-five percent confidence intervals will be provided for descriptive statistics. | Up to 6 months |
| Tissue Acquisition during endoscopy procedure | Will evaluate the ability of the DC to deliver tools to obtain adequate tissue samples (biopsies) to be analyzed for the presence or absence of disease, including cancer, infection, or other conditions in subjects with indeterminate strictures. Will use descriptive analysis with sensitivity, specificity, accuracy, median and IQR plus operating characteristics of visualization and sampling in those patients with indeterminate strictures. Will evaluate the diagnostic efficacy of the novel biopsy forceps in the context of indeterminate biliary strictures and provide robust evidence for clinical decision-making. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | Will evaluate the total procedure time for bile duct stones. | Up to 6 months |
| Product performance evaluation as rated by the endoscopist operating the DPS System | Will evaluate the number of procedures required to achieve bile duct stone clearance after referral. Will summarize with descriptive statistics and report success rates. Ninety-five percent confidence intervals will be provided for descriptive statistics. |
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Inclusion Criteria:
Provision to sign and date the consent form;
Adult patients ≥ 21 years old;
Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:
Willing and able to follow study procedures and comply with study follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodolfo Hernandez | Contact | 303-724-1870 | Rodolfo.Hernandez@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtiy of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to 6 months |
| DPS Functionality during Endoscopy Procedures | Will assess whether the DPS functioned as intended in combination with the commercially available accessories. Functioned as intended is defined as the ability to set up, provide visualization, deliver the accessory to the target location, use of the accessory according to the instructions for use. Will summarize with descriptive statistics and report success rates. | Up to 6 months |
| Ergonomics | Will evaluate ergonomics by collecting anthropometric data from physician users. Will provide product performance evaluation data. | Up to 6 months |
| Lithotripsy fragmentation time | Will evaluate lithotripsy fragmentation time for bile duct stones. Will summarize with descriptive statistics and report success rates. | Up to 6 months |
| Product Performance | Will evaluate product performance for indeterminate biliary strictures as rated by the endoscopist operating the DPS system. Will summarize with descriptive statistics and report success rates. | Up to 6 months |
| Usability | Will assess usability by the System Usability Scale. Will provide product performance evaluation data. | At the completion of the study |
| Visualization of biliary strictures | Will evaluate the ability to adequately visualize biliary strictures, including the presence of both neoplastic (irregular nodular mucosa, irregular papillary projections, intraductal or villous mass, dilated and tortuous vessels with branching, infiltrative stricture, ulceration, and contact friability/ease of oozing) and benign (concentric, bandlike scar, uniform projections, thin vessels) characteristics. Will summarize with descriptive statistics and report success rates. | Up to 6 months |
| Visualization of stone or stricture characteristics | Will evaluate usability by the ability to visualize stone or stricture characteristics as rated by the endoscopist operating the DPS system. | Up to 6 months |
| User satisfaction | Will assess user satisfaction with the Net Promoter Score. Will provide product performance evaluation data. | At the completion of the study |
| Passing of device to target area | Will evaluate usability by the ability to pass the lithotripsy device and/or stone removal device to the target area as rated by the endoscopist operating the DPS system. | Up to 6 months |
| Work | Will assess the subjective assessment of work by the National Aeronautics and Space Administration-Task | After each case |
| Bile duct stone recurrence rate | Will evaluate the bile duct stone recurrence rate. Will summarize with descriptive statistics and report success rates. | At 6 months |
| D001649 |
| Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |