Status:
TERMINATED
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
Lead Sponsor:
Medtronic - MITG
Conditions:
Upper GI Bleeding
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
1. 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 de...
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 B...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01448382
Start Date
October 1 2011
End Date
December 1 2015
Last Update
July 31 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rambam medical center
Haifa, Israel