| ID | Type | Description | Link |
|---|---|---|---|
| IRB #041707 | Other Identifier | George Washington University Institutional Review Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
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).
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 department.Within 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Control | Active Comparator | Video Capsule Endoscopy will be administered during ED, but video will not be read until after inpatient EGD. Subject will have hospital admission with an EGD conducted during hospital stay. |
|
| Experimental | Experimental | Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam UGI | Device | An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Discharged for Outpatient Management of Upper GI Bleeds | Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Rate of Video Capsule Endoscopy | Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With VCE Procedure | 30 Days | |
| GI Physician Final Read and Site Physician Agreement on VCE Results | 30 Days | |
| Number of Participants With Serious Adverse Events at Day 7 and Day 30 |
Inclusion Criteria:
1. Individuals aged ≥ 18 years presenting to the Emergency Department with likely upper GI bleed (bloody emesis and/or coffee ground vomiting and/or melena) that has occurred within the previous 48 hours.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Meltzer, MD | George Washington University- Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| Duke University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23398660 | Derived | Meltzer AC, Ali MA, Kresiberg RB, Patel G, Smith JP, Pines JM, Fleischer DE. Video capsule endoscopy in the emergency department: a prospective study of acute upper gastrointestinal hemorrhage. Ann Emerg Med. 2013 Apr;61(4):438-443.e1. doi: 10.1016/j.annemergmed.2012.11.008. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Control | Standard of Care: Patient was admitted to hospital for care and received in-patient EGD. |
| FG001 | Experimental | PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Control | Standard of Care: Patient was admitted to hospital for care and received in-patient EGD. |
| BG001 | Experimental | PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Discharged for Outpatient Management of Upper GI Bleeds | Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds. | Posted | Count of Participants | Participants | 30 Days |
|
All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were monitored/assessed at Day 7 and Day 30
No adverse events were elicited at day 7 or day 30
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Control | Standard of Care: Patient was admitted to hospital for care and received in-patient EGD. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Meltzer | George Washington University | 202-741-2952 | ameltzer@mfa.gwu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2019 | Aug 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2019 | Aug 13, 2021 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care | Other | Patient was admitted to hospital for care and received in-patient EGD. |
|
|
Assess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group) |
| 30 Days |
| ED Length of Stay | 30 Days |
| Hospital Length of Stay | 30 days |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Detection Rate of Video Capsule Endoscopy | Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation. | This is a subgroup analysis. The reason only the experimental arm is reported here is because only the experimental arm got the VCE. | Posted | Number | participants | 30 Days |
|
|
|
| Other Pre-specified | Patient Satisfaction With VCE Procedure | Not Posted | 30 Days | Participants |
| Other Pre-specified | GI Physician Final Read and Site Physician Agreement on VCE Results | Not Posted | 30 Days | Participants |
| Other Pre-specified | Number of Participants With Serious Adverse Events at Day 7 and Day 30 | Assess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group) | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Other Pre-specified | ED Length of Stay | Not Posted | 30 Days | Participants |
| Other Pre-specified | Hospital Length of Stay | Not Posted | 30 days | Participants |
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Experimental | PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract. | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| Title | Measurements |
|---|---|
|
| Coffee ground blood |
|
| Fresh blood or evidence of active bleeding |
|
| Other sources of non-variceal bleeding / pathology |
|
| VCE passed the pylorus |
|
| Needs endoscopic hemostasis |
|