Back to results

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

About this trial

This is an interventional diagnostic trial for Anemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs