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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820182
• Other study ID #: 2010-023341-29
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2023
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Angiodysplasia
• Gastrointestinal Bleedings
• Gastrointestinal Hemorrhage
• Hemorrhage
• Méléna
• Polyps

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot	Capso Vision, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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