Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule
Primary Purpose
Anemia, Gastrointestinal Bleedings, Méléna
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
capsule endoscopies
Sponsored by
About this trial
This is an interventional diagnostic trial for Anemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
capsocam capsula
Arm Description
capsocam capsula readings
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01820182
First Posted
March 21, 2013
Last Updated
September 18, 2023
Sponsor
Hôpital Edouard Herriot
Collaborators
Capso Vision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01820182
Brief Title
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule
Official Title
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Edouard Herriot
Collaborators
Capso Vision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Gastrointestinal Bleedings, Méléna, Angiodysplasia, Polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
capsocam capsula
Arm Type
Experimental
Arm Description
capsocam capsula readings
Intervention Type
Device
Intervention Name(s)
capsule endoscopies
Other Intervention Name(s)
Pillcam SB2, Capsocam
Intervention Description
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
Primary Outcome Measure Information:
Title
number of discordant films between the two capsules with two different readers
Description
Reading of the two capsules film is randomized order by two different readers in each center
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saurin JS Jean Christophe, Msd
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule
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