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

Medtronic

Status and phase

Terminated

Phase 1

Conditions

Upper GI Bleeding

Treatments

Device: PillCam® capsule with Given PillCam® Platform

Study type

Interventional

Funder types

Industry

Identifiers

NCT01448382

RD-401

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.