Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03458000
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2018-03-01
Brief Title:
Capsule Endoscopy for HEmorrhage in the ER
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Capsule Endoscopy for Hemorrhage in the ER
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
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:
CHEER
Brief Summary:
This is a multi-center randomized controlled trial examining the use of Video Capsule Endoscopy VCE to discharge low-moderate risk patients with suspected upper gastrointestinal bleeds UGIB from the Emergency Department ED The investigators will enroll 100 subjects at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk assessment to an Active Control AC group who receive inpatient upper endoscopy EGD
Detailed Description:
Video capsule endoscopy VCE was initially approved in 2001 by the Food and Drug Administration VCE offers potential advantages over traditional EGD including the ability to be performed 24 hours a day without sedation and interpreted at the bedside by emergency physicians In addition VCE is much less invasive is painless and enables the patient to pursue normal daily activities after the procedure
Our primary goal is to test whether ED Video Capsule Endoscopy VCE is able to safely discharge low risk patients for outpatient evaluation and management Our secondary objective is to estimate the sensitivity and specificity of VCE compared to subsequent EGD in the detection of serious bleeding lesions in the upper gastrointestinal GI tract
Research Coordinator will screen potential patients with signs of upper GI bleeding Patients who screen as eligible will be approached about potential interest to review of inclusion and exclusion criteria and obtain informed consent Research Coordinator will calculate traditional risk stratification scores and once enrolled all subjects will be randomized to either Active Control AC admission plus EGD within hospital stay or experimental Capsule Endoscopy Risk Assessment CERA in ED Only patients randomized to the experimental arm will receive video capsule endoscopy in the emergency departmentWithin 2 hours of presenting to the ED patient will ingest video capsule-- RC will monitor progress on real-time viewer for passage through pylorus Upon passing the pylorus we will record 5 more minutes of video or until battery runs out - whichever occurs first Patient data will be completed using a standardized data collection tool including the following elements chief complaint of patient history of present illness past medical history pertinent lab findings current medications vital signs focused physical exam findings and all relevant treatments administered during the ED and hospital stay
For Active Control AC group each patient will be admitted During hospital admission EGD will be performed on all subjects and hemostasis therapy applied as necessary The study team decided against mandating that EGD be performed within 24 hours of hospital admission
Our primary goal is to test whether ED Video Capsule Endoscopy VCE is able to safely discharge low risk patients for outpatient evaluation and management Our secondary objective is to estimate the sensitivity and specificity of VCE compared to subsequent EGD in the detection of serious bleeding lesions in the upper gastrointestinal GI tract
Research Coordinator will screen potential patients with signs of upper GI bleeding Patients who screen as eligible will be approached about potential interest to review of inclusion and exclusion criteria and obtain informed consent Research Coordinator will calculate traditional risk stratification scores and once enrolled all subjects will be randomized to either Active Control AC admission plus EGD within hospital stay or experimental Capsule Endoscopy Risk Assessment CERA in ED Only patients randomized to the experimental arm will receive video capsule endoscopy in the emergency departmentWithin 2 hours of presenting to the ED patient will ingest video capsule-- RC will monitor progress on real-time viewer for passage through pylorus Upon passing the pylorus we will record 5 more minutes of video or until battery runs out - whichever occurs first Patient data will be completed using a standardized data collection tool including the following elements chief complaint of patient history of present illness past medical history pertinent lab findings current medications vital signs focused physical exam findings and all relevant treatments administered during the ED and hospital stay
For Active Control AC group each patient will be admitted During hospital admission EGD will be performed on all subjects and hemostasis therapy applied as necessary The study team decided against mandating that EGD be performed within 24 hours of hospital admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 041707 | OTHER | George Washington University Institutional Review Board | None |