Trials / Unknown
UnknownNCT03685903
Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Capso Vision, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CapsoCam® Plus (SV-3) capsule endoscope | Endoscope Capsule |
Timeline
- Start date
- 2018-09-26
- Primary completion
- 2020-07-01
- Completion
- 2020-09-15
- First posted
- 2018-09-26
- Last updated
- 2020-05-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03685903. Inclusion in this directory is not an endorsement.