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| Name | Class |
|---|---|
| Capso Vision, Inc. | INDUSTRY |
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Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.
Objectives
Main objective
To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k>0,6
Secondary objectives
To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capsocam capsula | Experimental | capsocam capsula readings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsule endoscopies | Device | Patients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel |
| Measure | Description | Time Frame |
|---|---|---|
| number of discordant films between the two capsules with two different readers | Reading of the two capsules film is randomized order by two different readers in each center | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saurin JS Jean Christophe, Msd | Principal Investigator |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D016888 | Angiodysplasia |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053704 | Capsule Endoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
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|
|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |