NCT01820182

Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule

Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Hôpital Edouard Herriot · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Anemia
• Gastrointestinal Bleedings
• Méléna
• Angiodysplasia
• Polyps

Interventions

Type	Name	Description
DEVICE	capsule 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

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2013-03-28
• Last updated: 2023-09-21

Regulatory

• FDA-regulated device study