Back to resultsEvaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
Primary Purpose
Upper GI Bleeding
Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
PillCam® capsule with Given PillCam® Platform
Sponsored by
About this trial
This is an interventional diagnostic trial for Upper GI Bleeding
Eligibility Criteria
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.
Sites / Locations
- Rambam medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy volunteers
GI bleeding subjcets
Arm Description
healthy volunteers
Symptomatic patients referred to undergo standard Gastroscopy (EGD) as part of their standard medical care
Outcomes
Primary Outcome Measures
Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract
Secondary Outcome Measures
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)
Number, type and severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01448382
Brief Title
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
Official Title
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This study is designed to support the development of a novel blood sensing detector embedded in a PillCam® capsule and to provide initial evaluation of its performance in humans. The device is named Blood Sensing Capsule (BSC), and is based on the Given PillCam® Platform with a modified capsule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper GI Bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
healthy volunteers
Arm Title
GI bleeding subjcets
Arm Type
Experimental
Arm Description
Symptomatic patients referred to undergo standard Gastroscopy (EGD) as part of their standard medical care
Intervention Type
Device
Intervention Name(s)
PillCam® capsule with Given PillCam® Platform
Other Intervention Name(s)
CE
Intervention Description
capsule endoscopy
Primary Outcome Measure Information:
Title
Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
Number, type and severity of adverse events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehuda Chowers, PhD.
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam medical center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
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