GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors — CLARINET  

Chronic Inflammatory Small Bowel Disease Clinical Trial

Official title: GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors

Status Completed

Clinical Trial Summary

Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery.

Clinical Trial Description

Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouchsurgery.

The samples will be collected into sealed plastic containers, clearly labeled with "Biohazard" stickers and patient's code and be kept on ice for up to 30min and then freezed in -20deg to -80deg.

Characterization and quanification of small molecules- and protein biomarkers of GI diseases such as IBD will be performed. ;

Related Conditions & MeSH terms

• Chronic Inflammatory Small Bowel Disease

• NCT number: NCT02797535
• Study type: Interventional
• Source: Medtronic - MITG
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Completion date: February 7, 2019