Anemia, Angiodysplasia, Gastrointestinal Bleedings, Méléna, Polyps
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEcapsule endoscopies
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
Sponsors
Capso Vision, Inc.
Hôpital Edouard Herriot
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* over 18 years old * obscure digestive bleeding justifying capsule endoscopy * complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation * absence of concomittent ongoing study * absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy * filled inform consent * no implanted pace maker * patient being affiliated to the CPAM
Exclusion criteria
* under 18 years old * oral iron within 8 days before capsule endoscopy * gastroparesis * pacemaker * swallowing troubles * presence of oclusive symptoms suspected Crohn's disease nor of previous small bowel radiotherapy * pregnancy or risk of pregnancy without efficient oral contraception * absence of written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of discordant films between the two capsules with two different readers | 14 days | Reading of the two capsules film is randomized order by two different readers in each center |
Outcome results
None listed