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

Medtronic

Status: Completed

Conditions: Chronic Inflammatory Small Bowel Disease

Treatments: Procedure: Endoscopy procedures

Study type: Interventional

Funder types: Industry

Identifiers

NCT02797535

COVGIBD0533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects ages 18-75 years
• Subjects referred to endoscopic procedures gastroscopy, esophagogastroduodenoscopy (EGD), colonoscopy, single balloon or double balloon enteroscopy Or Subjects having ileostomy or colostomy bags Or Subjects having an ileal pouch
• Subjects agree to sign consent form

Exclusion criteria

• Patients has any medical condition that requires special handling of body fluids beyond routine infection control measures (i.e. standard surgical gloves)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

GI fluids samples collection

Other group

Description:

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.

Treatment:

Procedure: Endoscopy procedures