Trial Outcomes & Findings for Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding (NCT NCT03955055)
NCT ID: NCT03955055
Last Updated: 2023-07-10
Results Overview
Rate of detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner
Results posted on
2023-07-10
Participant Flow
Participant milestones
| Measure |
Early Capsule Group
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
20
|
|
Overall Study
COMPLETED
|
14
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding
Baseline characteristics by cohort
| Measure |
Early Capsule Group
n=15 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.47 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
66.45 years
STANDARD_DEVIATION 16.09 • n=7 Participants
|
65.17 years
STANDARD_DEVIATION 14.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is soonerPopulation: One participant excluded, unable to swallow capsule
Rate of detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]
Outcome measures
| Measure |
Early Capsule Group
n=14 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Rate of Detection of Bleeding
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is soonerPopulation: Time point data was missing on several participants.
Time to detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]
Outcome measures
| Measure |
Early Capsule Group
n=3 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=6 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Time to Detection of Bleeding
|
20.9 hours
Standard Deviation 1.9
|
17.7 hours
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Enrollment to time of admission as measured in hours, up to 720 hours, whichever is soonerPopulation: One participant was excluded due to inability to swallow capsule.
Rate of in-patient admissions to the hospital
Outcome measures
| Measure |
Early Capsule Group
n=14 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Admission Rate
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 720 hoursPopulation: One participant was excluded due to inability to swallow capsule.
Rate of in-patient re-admissions to the hospital
Outcome measures
| Measure |
Early Capsule Group
n=14 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Re-admission Rate
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Enrollment to time of discharge as measured in hours, up to 720 hours, whichever is soonerPopulation: One participant excluded due to inability to swallow capsule.
Length of hospital stay measured in hours
Outcome measures
| Measure |
Early Capsule Group
n=14 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Hospital Length of Stay
|
143.7 hours
Standard Deviation 102.3
|
140.9 hours
Standard Deviation 80.5
|
SECONDARY outcome
Timeframe: Enrollment to 720 hoursPopulation: One participant excluded due to inability to swallow capsule.
Number of endoscopic procedures performed
Outcome measures
| Measure |
Early Capsule Group
n=14 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Endoscopic Procedures
|
1.9 procedures
Standard Deviation 0.66
|
1.35 procedures
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Enrollment to 720 hoursNumber of therapeutic procedures performed
Outcome measures
| Measure |
Early Capsule Group
n=14 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Therapeutic Procedures
|
0.29 procedures
Standard Deviation 0.47
|
0.35 procedures
Standard Deviation 0.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 720 hoursPopulation: One participant excluded inability to swallow capsule.
Percentage of participants who experienced a complication.
Outcome measures
| Measure |
Early Capsule Group
n=14 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Complication Rates
|
6 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to one yearNumber of blood products transfused
Outcome measures
| Measure |
Early Capsule Group
n=15 Participants
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 Participants
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Blood Product Transfusions
|
1.8 units of packed red blood cells
Standard Deviation 1.6
|
2.2 units of packed red blood cells
Standard Deviation 2.7
|
Adverse Events
Early Capsule Group
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard of Care Work-up
Serious events: 3 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Early Capsule Group
n=14 participants at risk
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 participants at risk
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Gastrointestinal disorders
Melena
|
7.1%
1/14 • Number of events 1 • 30 days
|
0.00%
0/20 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/14 • 30 days
|
5.0%
1/20 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
7.1%
1/14 • Number of events 1 • 30 days
|
5.0%
1/20 • Number of events 1 • 30 days
|
|
Cardiac disorders
Hypoxemia
|
0.00%
0/14 • 30 days
|
5.0%
1/20 • Number of events 1 • 30 days
|
|
Immune system disorders
Acute allergic reaction
|
7.1%
1/14 • Number of events 1 • 30 days
|
0.00%
0/20 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Coronavirus
|
7.1%
1/14 • Number of events 1 • 30 days
|
0.00%
0/20 • 30 days
|
Other adverse events
| Measure |
Early Capsule Group
n=14 participants at risk
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Video Capsule Endoscopy: Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
|
Standard of Care Work-up
n=20 participants at risk
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
|
|---|---|---|
|
Gastrointestinal disorders
Capsule retention
|
7.1%
1/14 • Number of events 1 • 30 days
|
0.00%
0/20 • 30 days
|
Additional Information
Anne Foley, Senior Clinical Research Coordinator
UMass Chan Medical School
Phone: 774-442-4098
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place