Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Upper GI Bleeding	Device: PillCam® capsule with Given PillCam® Platform	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Gastrointestinal Bleeding

U.S. FDA Resources

Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:

Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number, type and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2011
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Healthy volunteers healthy volunteers	Device: PillCam® capsule with Given PillCam® Platform capsule endoscopy Other Name: CE
Experimental: GI bleeding subjcets Symptomatic patients referred to undergo standard Gastroscopy (EGD) as part of their standard medical care	Device: PillCam® capsule with Given PillCam® Platform capsule endoscopy Other Name: CE

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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:
1. 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
2. Subject has ongoing overt gastrointestinal bleeding with hematochezia or melena
3. Subject has Iron Deficiency Anemia ,FOBT(+) and negative colonoscopy examination
4. 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448382

Locations

Israel
Rambam medical center
Haifa, Israel

Sponsors and Collaborators

Given Imaging Ltd.

Investigators

Principal Investigator:

Yehuda Chowers, PhD.

Rambam Health Care Campus

More Information

No publications provided

Responsible Party:	Given Imaging Ltd.
ClinicalTrials.gov Identifier:	NCT01448382 History of Changes
Other Study ID Numbers:	RD-401
Study First Received:	October 4, 2011
Last Updated:	October 11, 2012
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013