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

Chronic Inflammatory Small Bowel Disease Clinical Trial

— CLARINET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797535
• Other study ID #: COVGIBD0533
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 7, 2019

Study information

• Verified date: February 2019
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Inflammatory Small Bowel Disease

Intervention

Procedure:
• 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.

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	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.	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.	3 years