Trial Outcomes & Findings for Capsule Endoscopy for HEmorrhage in the ER (NCT NCT03458000)
NCT ID: NCT03458000
Last Updated: 2023-06-01
Results Overview
Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
30 Days
Results posted on
2023-06-01
Participant Flow
Participant milestones
| Measure |
Active Control
Standard of Care: Patient was admitted to hospital for care and received in-patient EGD.
|
Experimental
PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capsule Endoscopy for HEmorrhage in the ER
Baseline characteristics by cohort
| Measure |
Active Control
n=13 Participants
Standard of Care: Patient was admitted to hospital for care and received in-patient EGD.
|
Experimental
n=11 Participants
PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.0 years
n=5 Participants
|
55.0 years
n=7 Participants
|
51.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysOur primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.
Outcome measures
| Measure |
Active Control
n=13 Participants
Standard of Care: Patient was admitted to hospital for care and received in-patient EGD.
|
Experimental
n=11 Participants
PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
|
|---|---|---|
|
Number of Participants Discharged for Outpatient Management of Upper GI Bleeds
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: This is a subgroup analysis. The reason only the experimental arm is reported here is because only the experimental arm got the VCE.
Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation.
Outcome measures
| Measure |
Active Control
n=11 Participants
Standard of Care: Patient was admitted to hospital for care and received in-patient EGD.
|
Experimental
PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
|
|---|---|---|
|
Detection Rate of Video Capsule Endoscopy
Clean stomach and duodenum i.e. no fresh blood /coffee grounds
|
8 participants
|
—
|
|
Detection Rate of Video Capsule Endoscopy
Upper GI pathology non-causative/ incidental.
|
1 participants
|
—
|
|
Detection Rate of Video Capsule Endoscopy
Coffee ground blood
|
2 participants
|
—
|
|
Detection Rate of Video Capsule Endoscopy
Needs endoscopic hemostasis
|
2 participants
|
—
|
|
Detection Rate of Video Capsule Endoscopy
A low grade non-Variceal lesion (Forrest IIc, III)
|
1 participants
|
—
|
|
Detection Rate of Video Capsule Endoscopy
Fresh blood or evidence of active bleeding
|
1 participants
|
—
|
|
Detection Rate of Video Capsule Endoscopy
Other sources of non-variceal bleeding / pathology
|
3 participants
|
—
|
|
Detection Rate of Video Capsule Endoscopy
VCE passed the pylorus
|
9 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 DaysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 DaysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 DaysAssess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group)
Outcome measures
| Measure |
Active Control
n=13 Participants
Standard of Care: Patient was admitted to hospital for care and received in-patient EGD.
|
Experimental
n=11 Participants
PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events at Day 7 and Day 30
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 DaysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
Adverse Events
Active Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place