Trial Outcomes & Findings for Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy (NCT NCT02609100)
NCT ID: NCT02609100
Last Updated: 2018-06-20
Results Overview
Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Up to twenty four hours
Results posted on
2018-06-20
Participant Flow
Participant milestones
| Measure |
Video Capsule Endoscopy
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy
Baseline characteristics by cohort
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
Video Capsule Endoscopy: Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. It is of greatest use in identifying points of bleeding and ulcers.
1.0 X 2.5 cm 'pill' containing a camera
|
Next Day Colonoscopy
n=2 Participants
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
71.5 years
n=5 Participants
|
79.5 years
n=7 Participants
|
75.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to twenty four hoursVideo Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to one hourColonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 7 daysTherapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Therapeutic Yield of Video Capsule Endoscopy
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 7 daysTherapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Therapeutic Yield of Colonoscopy
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 60 daysNumber of blood units transfused measured in units of packed red blood cells
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
n=2 Participants
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Number of Blood Units Transfused
|
3 Units of blood
Interval 2.0 to 4.0
|
0 Units of blood
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 60 daysIncludes repeat endoscopies or imaging
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
n=2 Participants
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 60 daysThe duration of hospital stay will be recorded in number of days
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
n=2 Participants
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Duration of Hospital Stay
|
8 Days
Interval 6.0 to 10.0
|
14.5 Days
Interval 14.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to 60 daysAdverse events related to the video capsule endoscopy and colonoscopy will be recorded
Outcome measures
| Measure |
Video Capsule Endoscopy
n=2 Participants
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
|
Next Day Colonoscopy
n=2 Participants
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
|
|---|---|---|
|
Procedure Related Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
Adverse Events
Video Capsule Endoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Next Day Colonoscopy
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
Dr. Vladimir M. Kushnir
Washington University School of Medicine in St. Louis
Phone: 314-362-3685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place