Celiac Disease, Crohn Disease, Inflammatory Bowel Disease, Intestinal Disease, Ulcer
Conditions
Keywords
intestinal disease, inflammatory bowel disease, crohn disease, ulcer, celiac disease, angioectasia, polyp
Brief summary
The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2.
Detailed description
This is a prospective, randomized, comparative multi-center site study. The study will be conducted at 5 to 10 clinical sites. Up to 120 subjects will be enrolled in the study in order to obtain complete endoscopic results involving at least 98 subjects.
Interventions
DEVICEPillCam SB2 capsule
Capsule Endoscopy system
DEVICECapsoCam SV-1
Capsule endoscopy
Sponsors
Capso Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female between 18 to 85 years of age (inclusive). 2. Willing and able to provide written informed consent. 3. Subjects with suspected small bowel disease who are referred for capsule endoscopy. Suspected small bowel disease includes suspected small bowel bleeding (including obscure gastrointestinal bleed), suspected or established Crohn's Disease \[should have had patency capsule, CT or MR enterography before entry\], suspected or known celiac disease, suspected small bowel tumor or familial polyposis syndrome. 4. If subject was referred for capsule endoscopy (CE) for identification of occult GI bleeding, has the subject undergone a non-diagnostic esophagoduodenoscopy and colonoscopy as part of their evaluation, OR has the subject had continued bleeding requiring transfusion since the initial evaluation, OR does the subject have the following hematocrit values \<31% in males or \<28% in females.
Exclusion criteria
1. Subjects who had a prior negative capsule endoscopy (within 1 year of study). 2. Known or suspected obstruction or stricture unless patency capsule confirms patency. 3. Known or suspected gastrointestinal perforation. 4. Known or suspected small bowel diverticuli. 5. Known swallowing disorder or the inability or unwillingness to swallow pills. 6. Radiation or chemotherapy induced enteritis. 7. History of Zenker's or known duodenal or jejunal diverticula. 8. Isolated diarrhea or isolated abdominal pain without alarm signs or symptoms 9. Subjects who are high risk for undergoing surgical interventions (i.e., to CONFIDENTIAL CapsoVision Protocol SV-1 Revision: October 17, 2011 7 remove the capsule when capsule retention occurs). 10. Subjects with DNR/DNI do not resuscitate/do not intubate status. 11. Known or suspected gastrointestinal dysmotility. 12. Presence of cardiac pacemaker, implanted defibrillator or other electromedical implant. 13. History of skin reaction to adhesives. 14. Subjects who in the Investigator's opinion should not consume the 2L GoLytely and 10 mg bisacodyl study drugs, because it could pose a significant additional risk to the subject because of the subject's medical condition. 15. Subjects who are scheduled for an MRI within 30 days of the last study visit. 16. Pregnancy; females of childbearing potential must have a negative urine pregnancy test at screening. 17. Prisoners. 18. Mental and/or physical condition precluding compliance with the study and/or device instructions. 19. Participation in another clinical study within past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normal vs Abnormal, Overall Impression | Study Completion | The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2 | Study Completion | Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers. |
| Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Study Completion | Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result. |
| Preference Between CapsoCam SV-1 and PillCam SB2 | Study Completion | Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects recruited from population of patients prescribed capsule endoscopy for OGIB
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants PillCam SB2 capsule and CapsoCam SV-1 capsule in random order, PillCam SB2 capsule: Capsule Endoscopy system, CapsoCam SV-1: Capsule endoscopy
The analysis population consisted of subjects that swallowed the capsules. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Data Not Analyzable | 5 | 1 |
| Overall Study | Subject Did Not Ingest Capsules | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 15.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 104 Participants |
| Region of Enrollment Canada | 40 participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 120 |
| serious Total, serious adverse events | 2 / 120 |
Outcome results
Primary
Normal vs Abnormal, Overall Impression
The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
Time frame: Study Completion
Population: Note: Each participant swallowed both Pill Cam and CapsoCam approximately 30-60 minutes apart. the order in which the cams were swalloed was randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CapsoCam SV-1 | Normal vs Abnormal, Overall Impression | Abnormal | 42 participants |
| CapsoCam SV-1 | Normal vs Abnormal, Overall Impression | Normal | 72 participants |
| PillCam SB2 | Normal vs Abnormal, Overall Impression | Abnormal | 42 participants |
| PillCam SB2 | Normal vs Abnormal, Overall Impression | Normal | 72 participants |
Comparison: There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.p-value: 195% CI: [68.68, 83.93]McNemar
Secondary
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.
Time frame: Study Completion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CapsoCam SV-1 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Normal | 71 participants |
| CapsoCam SV-1 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Vascular | 24 participants |
| CapsoCam SV-1 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Mass/Polyp | 1 participants |
| CapsoCam SV-1 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Blood | 1 participants |
| CapsoCam SV-1 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Ulcerative | 15 participants |
| CapsoCam SV-1 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Other | 2 participants |
| PillCam SB2 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Ulcerative | 14 participants |
| PillCam SB2 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Normal | 70 participants |
| PillCam SB2 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Blood | 3 participants |
| PillCam SB2 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Vascular | 21 participants |
| PillCam SB2 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Other | 2 participants |
| PillCam SB2 | Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Mass/Polyp | 4 participants |
p-value: 0.97295% CI: [63.07, 79.36]Bowkers
Secondary
Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2
Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.
Time frame: Study Completion
Population: For CapsoCam SV-1 data was captured for 112 subjects total transit time. For PillCam SB2, data was captured for 110 subjects for total transit time.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CapsoCam SV-1 | Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2 | 4.1 hours | Standard Deviation 1.85 |
| PillCam SB2 | Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2 | 3.6 hours | Standard Deviation 1.56 |
Secondary
Preference Between CapsoCam SV-1 and PillCam SB2
Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects
Time frame: Study Completion
Population: For CapsoCam SV-1 and PillCam SB2 preference data was captured for 113 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CapsoCam SV-1 | Preference Between CapsoCam SV-1 and PillCam SB2 | 89 participants |
| PillCam SB2 | Preference Between CapsoCam SV-1 and PillCam SB2 | 24 participants |