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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01448382
First received: October 4, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose
  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 detection performances in human.
  2. 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:


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 2014
Estimated Primary Completion Date: February 2014 (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:

  1. Subject has Dysphagia, odynophagia, known swallowing disorder or history of Zencker's diverticulum
  2. Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation
  3. Subject has history of prior bowel obstruction
  4. Subject suffers UGI hemorrhage with hemodynamic shock requiring urgent endoscopy
  5. 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
  6. Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
  7. Pregnancy or nursing mothers
  8. Subject has known allergy to conscious sedation medications
  9. Presence of an electro-medical device (pacemaker or internal cardiac defibrillator)
  10. Subject has altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule
  11. Known allergy to erythromycin
  12. Subject is currently or within previous 30 days participating in another clinical study that may directly or indirectly affect the results of this study
  13. Subject is not able to provide written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 2, 2013
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 24, 2014