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

Not Applicable

Completed

• Conditions: Chronic Inflammatory Small Bowel Disease
• Interventions: Procedure: Endoscopy procedures

• Registration Number: NCT02797535
• Lead Sponsor: Medtronic - MITG

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Study Start: 2016-07
• Status Verified: 2019-02
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GI fluids samples collection	Endoscopy procedures	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.

Primary Outcome Measures

Name	Time	Method
Characterization and quantification of small molecules- and protein biomarkers of GI diseases will be performed. Examples of such biomarkers include - calprotectin, lactoferrin, albumin, hemoglobin, CEA, CA19-9, CA 72-4, LYVE-1, REG1A, TFF1 and ammonia.	3 years	The concentration of the biomarkers in the collected fluids from different parts of the GI will be determined by quantitative assays - such as ELISA or lateral flow immunoassay or mass spectrometry. Concentration will be determined in mg/ml.

Trial Locations

Locations (2)

The Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel