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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PillCam SB2 then CapsoCam SV-1 | Other | PillCam SB2 capsule then CapsoCam SV-1 capsule |
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| CapsoCam SV-1 then PillCam SB2 | Other | CapsoCam SV-1 capsule then PillCam SB2 capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam SB2 capsule | Device | Capsule Endoscopy system |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Completion |
| Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shabana F Pasha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shabana F. Pasha, MD | Scottsdale | Arizona | 85259 | United States | ||
| Gastro Health |
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Subjects recruited from population of patients prescribed capsule endoscopy for OGIB
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| ID | Title | Description |
|---|---|---|
| FG000 | CapsoCam SV-1 Then PillCam SB2 | Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2 |
| FG001 | PillCam SB2 Then CapsoCam SV-1 | Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| CapsoCam SV-1 | Device | Capsule endoscopy |
|
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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. |
| Study Completion |
| 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 | Study Completion |
| Miami |
| Florida |
| 33173 |
| United States |
| University of Massachusetts, Worcester | Worcester | Massachusetts | 01655 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Ziad Younes, MD | Germantown | Tennessee | 38138 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Pacific Gastroenterology Associates GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| COMPLETED | This was a paired study with crossover with randomization. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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. | Note: Each participant swallowed both Pill Cam and CapsoCam approximately 30-60 minutes apart. the order in which the cams were swalloed was randomized. | Posted | Number | participants | Study Completion |
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| 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. | 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. | Posted | Mean | Standard Deviation | hours | Study Completion |
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| 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. | Posted | Number | participants | Study Completion |
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| 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 | For CapsoCam SV-1 and PillCam SB2 preference data was captured for 113 subjects. | Posted | Number | participants | Study Completion |
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Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | PillCam SB Capsule and CapsoCam SV-1 | 2 | 120 | 12 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Capsule Endoscope Retention | Gastrointestinal disorders | Systematic Assessment | Capsule Endoscopes (Both CapsoCam SV-1 and PillCam SB2) retained within the small bowel of each of two (2) enrolled subjects. Capsules were removed via surgical intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Tract discomfort or pain and nausea | Gastrointestinal disorders | Systematic Assessment | GI Tract discomfort or pain and nausea attributed to bowel preparation for the procedures by study investigators |
| |
| Malaise | Gastrointestinal disorders | Systematic Assessment | Malaise in one (1) subject |
| |
| Skin Irritation and Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin Irritation and itchiness secondary to adhesive tape used to secure PillCam SB2 wireless receiver |
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| Delayed Capsule Excretion | Gastrointestinal disorders | Systematic Assessment | Delayed Capsule Excretion: Capsule s not retrieved and returned to investigator/research site for analysis |
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| Right Kidney Pain | Renal and urinary disorders | Systematic Assessment | Right Kidney Pain: Cause unknown |
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| Migraine Headache | Nervous system disorders | Systematic Assessment | Migraine Headache in one (1) subject |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | CapsoVision, Inc. | 408-624-1488 | 117 | andra.thomas@capsovision.com |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D014456 | Ulcer |
| D002446 | Celiac Disease |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D053704 | Capsule Endoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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