- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01448382
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
Primary Scientific Objective
- Collect human clinical data to sustain the development of blood detection sensor and optimize its algorithm and parameters
- Preliminary evaluation of blood detection performances in human.
Secondary Scientific Objective
- Assessment of blood detection sensor ability to identify the anatomical location (i.e. Stomach, SB or Colon)
- Evaluation of capsule transit characteristics in the GI tract
- Evaluation of BBC capsule safety
Study Hypothesis:
It is estimated that by implementing a spectrophotometer technology in capsule and utilizing the unique characteristics of light absorption by blood in specific spectrum, the capsule will be able to automatically detect blood in the GI tract with high accuracy. As such, the system may be an add-on to video capsules to provide efficient and quick detection of blood presence (for example in OGBI patients) or as stand alone low cost capsule (without video) which could serve as a tool similar to standard FOBT.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Rambam Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Group A (Healthy subjects)
- Subject's age is 18 to 45 years old
- Subject is an healthy volunteer
- Subject agrees to sign the Informed Consent Form
Group B (Symptomatic Patients)
- Age ≥ 18 years
The subject was referred to Gastroscopy for at least one of the following reasons:
- History of acute, overt UGI hemorrhage, defined as hematemesis (fresh blood or coffee grounds) and/or melena within the 48 hours prior to patient presentation
- Subject has ongoing overt gastrointestinal bleeding with hematochezia or melena
- Subject has Iron Deficiency Anemia ,FOBT(+) and negative colonoscopy examination
- Other known or suspected cause of acute upper GI bleeding
- Subject agrees to sign the Informed Consent Form
Exclusion Criteria:
- Subject has Dysphagia, odynophagia, known swallowing disorder or history of Zencker's diverticulum
- Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation
- Subject has history of prior bowel obstruction
- Subject suffers UGI hemorrhage with hemodynamic shock requiring urgent endoscopy
- Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, incomplete colonoscopies due to obstructions or NSAID enteropathy
- Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
- Pregnancy or nursing mothers
- Subject has known allergy to conscious sedation medications
- Presence of an electro-medical device (pacemaker or internal cardiac defibrillator)
- Subject has altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule
- Known allergy to erythromycin
- Subject is currently or within previous 30 days participating in another clinical study that may directly or indirectly affect the results of this study
- Subject is not able to provide written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy volunteers
healthy volunteers
|
capsule endoscopy
Other Names:
|
Experimental: GI bleeding subjcets
Symptomatic patients referred to undergo standard Gastroscopy (EGD) as part of their standard medical care
|
capsule endoscopy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Agreement level between the blood detectors head to capsule video head in detecting subjects with blood per anatomical location (i.e. stomach, small bowel or colon)
Time Frame: 1 year
|
1 year
|
Number, type and severity of adverse events
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yehuda Chowers, PhD., Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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