Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT03685903
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2018-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
Sponsor:
Capso Vision, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: