GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors
CLARINET
1 other identifier
interventional
66
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2019
CompletedFebruary 15, 2019
February 1, 2019
2.6 years
April 25, 2016
February 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
GI fluids samples collection
OTHERGI 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients has any medical condition that requires special handling of body fluids beyond routine infection control measures (i.e. standard surgical gloves)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (2)
Sheba Medical Center
Ramat Gan, Israel
The Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Rami Eliakim, Prof.
Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2016
First Posted
June 13, 2016
Study Start
July 1, 2016
Primary Completion
February 7, 2019
Study Completion
February 7, 2019
Last Updated
February 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share