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

NCT01820182 | Completed DMC FDA Device

• 1 other identifier: 2010-023341-29
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Gastrointestinal Bleedings; Méléna; Angiodysplasia; Polyps

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

capsocam capsula

EXPERIMENTAL

capsocam capsula readings

Device: capsule endoscopies

Interventions

capsule endoscopies DEVICE

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

Also known as: Pillcam SB2, Capsocam

capsocam capsula

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Edouard Herriot: lead
• Capso Vision, Inc.: collaborator

MeSH Terms

Conditions

Anemia; Angiodysplasia; Polyps

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Saurin JS Jean Christophe, Msd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 28, 2013
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share