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

Hôpital Edouard Herriot

Status: Completed

Conditions: Anemia; Polyps; Gastrointestinal Bleedings; Méléna; Angiodysplasia

Treatments: Device: capsule endoscopies

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01820182

2010-023341-29

Details and patient eligibility

About

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.

Full 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

Enrollment: 73 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

73 participants in 1 patient group

capsocam capsula

Experimental group

Description:

capsocam capsula readings

Treatment:

Device: capsule endoscopies