Upper GI BleedingPhase 1NCT01448382
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
A Phase 1 study testing PillCam® capsule with Given PillCam® Platform in people with Upper GI Bleeding, run by Medtronic - MITG at 1 site in Israel.
Trial 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 detection performances in human. 2. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper GI Bleeding
- What is being tested?
- PillCam® capsule with Given PillCam® Platform
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read more
- 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.
Read the 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.
- Conditions
- Upper GI Bleeding
- Being tested
- PillCam® capsule with Given PillCam® Platform
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam® capsule with Given PillCam® PlatformDevice
Also called CE
capsule endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | healthy volunteers Receives: 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 Receives: Device: PillCam® capsule with Given PillCam® Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract
Measured: 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)
Measured: 1 year
Number, type and severity of adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper GI BleedingStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yehuda Chowers, PhD., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448382
- Sponsor's protocol ID
- RD-401
- Status last verified
- Dec 2015
- First submitted
- 4 Oct 2011
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01448382
- Acronym / sponsor ID
- RD-401
- Conditions
- Upper GI Bleeding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: PillCam® capsule with Given PillCam® Platformhealthy volunteers |
| GI bleeding subjcets | Experimental | Device: PillCam® capsule with Given PillCam® PlatformSymptomatic patients referred to undergo standard Gastroscopy (EGD) as part of their standard medical care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PillCam® capsule with Given PillCam® PlatformAlso: CEcapsule endoscopy | Device | GI bleeding subjcets, Healthy volunteers |
Primary outcome
Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract
Time frame: 1 year
2 secondary outcomes
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
Number, type and severity of adverse events
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehuda Chowers, PhD. principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PillCam® capsule with Given PillCam® Platform in people with Upper GI Bleeding, run by Medtronic - MITG at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement level between the blood detectors head to capsule video head in detecting subjects with blood in the GI tract (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.