Retrospective Collection of PillCam SB Movies

Inflammatory Bowel Disease, Crohn Disease Clinical Trial

— OCEAN  

Official title:

Retrospective Collection of PillCam SB Movies for Capsule Transit Time Analysis (OCEAN Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707289
• Other study ID #: COVGIBD0547
• Status: Completed
• Start date: May 2016
• Est. completion date: June 18, 2018

Study information

• Verified date: July 2018
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites, during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated.

Description:

Up to two hundred un-identified PillCam SB movies that were created between the year 2008 and the date the study was approved by the IRB, will be collected from 2 clinical sites, Sourasky and Sheba medical centers during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated by internal readers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 18, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Videos collected from any PillCam SB procedure

Exclusion Criteria:

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Disease, Crohn Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat-Gan
Israel	The Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transit time in the different sections of the GI according to PillCam SB movies (minutes)		Minutes