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

NCT01448382 | Terminated Phase 1

• 1 other identifier: RD-401
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Upper GI Bleeding

Outcome Measures

Primary Outcomes (1)

• Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract

  1 year

Secondary Outcomes (2)

• 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)

  1 year

• Number, type and severity of adverse events

  1 year

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

healthy volunteers

Device: PillCam® capsule with Given PillCam® Platform

GI bleeding subjcets

EXPERIMENTAL

Symptomatic patients referred to undergo standard Gastroscopy (EGD) as part of their standard medical care

Device: PillCam® capsule with Given PillCam® Platform

Interventions

PillCam® capsule with Given PillCam® Platform DEVICE

capsule endoscopy

Also known as: CE

GI bleeding subjcets; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Rambam medical center

Haifa, Israel

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yehuda Chowers, PhD.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 7, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 31, 2019

Record last verified: 2015-12

Locations

IL (1)