Barrett's EsophagusMA-76NCT00885469
PillCam® ESO 2 in Esophageal Pathologies
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease, run by Medtronic - MITG at 10 sites in United States.
Trial summary
Study Hypothesis: PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Gastroesophageal Reflux Disease
- How many people
- 101 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2007to Apr 2009
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known Barrett's Esophagus or chronic GERD
Who may be able to join
- Patient age is 18 years or older
- Patient is known or suspected to suffer from an esophageal disease based on his/her medical history and recent symptoms suggestive of GERD or BE
- Patient agrees and signs the Informed Consent Form
- Currently taking PPI for at least 28 days.
Who cannot join
- Patient has dysphagia
- Patient has known Zenker's Diverticulum
- Patient is known or is suspected to suffer from esophageal and/or intestinal obstruction
- Patient has a cardiac pacemakers or other implanted electro medical devices
- Patient who has undergone an EGD within past seven days
- Female patient is pregnant and/or lactating
Show all 15Show fewer
- Patient is expected to undergo Magnetic Resonance Imaging (MRI) examination within 7 days after ingestion of the capsule
- Patient has had a prior pelvic or abdominal surgery of the gastrointestinal tract (other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator such as appendectomy or uncomplicated cholecystectomy)
- Patient has any condition which precludes compliance with the study and/or device instructions
- Patient suffers from life threatening conditions
- Patient is currently participating in another clinical study
- Patient is on medications that may coat the esophagus such as iron or sulcrafate.
- Contraindication for any radiation or barium (e.g., sensitivity or allergy) required to confirm excretion of the capsule if necessary.
- Patient is currently suffering from conditions like allergy, illness (flu) or anything else that causes congestion, excessive salivation, etc. that could foster difficulty in swallowing the capsule or affect the clarity of the CE images.
- Contraindicated for use of laxatives, or surgery required to remove a capsule e.g., colonoscopy.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Department of VA Medical Affairs Medical Center of Kansas City
Kansas City, Missouri, 66160
Minnesota Gastroenterology
Minneapolis, Minnesota, 55446
New York Gastroenterology Assoicates
New York, New York, 10021
Oregon Health & Science University
Portland, Oregon, 97239-3098
Mayo Clinic
Rochester, Minnesota, 55905
Rockford Gastroenterolgy Assoicates
Rockford, Illinois, 61107
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Evaluation of PillCam® ESO 2 in Patients With Suspected Esophageal Pathologies
Study Hypothesis:
- PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis.
- PillCam™ ESO will demonstrate all safety parameters as compared to EGD
- PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD
Read the detailed description
Upper endoscopy (EGD) is employed to diagnose BE; however, the cost and invasiveness of this diagnostic tool limits its utilization in many patients (17). There is a need for an alternative, simple, and less invasive diagnostic tool for evaluating GERD patients and screening for BE. Esophageal capsule endoscopy (ECE) is a novel technique that offers non-invasive evaluation of esophageal pathology in gastroesophageal reflux disease (GERD) patients. The potential benefits of screening patients by Capsule Endoscopy (CE) are several. Detection of esophageal pathology during CE could select a subgroup of patients for upper endoscopy avoiding the risks and costs of an upper endoscopy in the majority. Other benefits include convenience, ability to perform the test on an outpatient basis in less than 30 minutes, patient acceptability, minimal loss of work time, safety, tolerability, the ability of non-physicians to screen patients, and potentially, improved compliance with screening recommendations. Recently, a new, high resolution capsule (ESO 2) with a larger field of view and better illumination than the previous CE has been introduced. A simplified ingestion protocol for CE that improves visualization of the Z-line has also been reported as well (17).
- Keywords
- known Barrett's Esophagus, Suspected Barrett's Esophagus, chronic GERD, known Barrett's Esophagus or chronic GERD
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with known Barrett's Esophagus or chronic GERD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard.
Measured: 7 days
Secondary outcomes (3)
Level of agreement (i.e. positive, negative and overall agreement parameters) between PillCam ESO 2 and standard EGD in classifying the Z-line following the ZAP score (Wallner et. al 2002), where Grades 0&I and grades II&III will be consolidated.
Measured: 7 days
Accuracy Parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting Esophagitis as compared to standard EGD, using unblinded EGD as the reference standard.
Measured: 7 days
Subjects' satisfaction will be assessed by a post procedure questionnaire
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startDec 2007
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Glen Eisen, MD, Principal investigator, Oregon Health and Science UniversityPrateek Sharma, MD, Principal investigator, Department of VA Medical Affairs Medical Center of Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885469
- Sponsor's protocol ID
- MA-76
- Acronym
- MA-76
- Status last verified
- Aug 2009
- First submitted
- 20 Apr 2009
- 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® ESO 2 in Patients With Suspected Esophageal Pathologies
- ClinicalTrials.gov ID
- NCT00885469
- Acronym / sponsor ID
- MA-76 / MA-76
- Keywords
- known Barrett's Esophagus, Suspected Barrett's Esophagus, chronic GERD, known Barrett's Esophagus or chronic GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Apr 2009 (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.
Study Hypothesis:
- PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis.
- PillCam™ ESO will demonstrate all safety parameters as compared to EGD
- PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD
Detailed description
Upper endoscopy (EGD) is employed to diagnose BE; however, the cost and invasiveness of this diagnostic tool limits its utilization in many patients (17). There is a need for an alternative, simple, and less invasive diagnostic tool for evaluating GERD patients and screening for BE. Esophageal capsule endoscopy (ECE) is a novel technique that offers non-invasive evaluation of esophageal pathology in gastroesophageal reflux disease (GERD) patients. The potential benefits of screening patients by Capsule Endoscopy (CE) are several. Detection of esophageal pathology during CE could select a subgroup of patients for upper endoscopy avoiding the risks and costs of an upper endoscopy in the majority. Other benefits include convenience, ability to perform the test on an outpatient basis in less than 30 minutes, patient acceptability, minimal loss of work time, safety, tolerability, the ability of non-physicians to screen patients, and potentially, improved compliance with screening recommendations. Recently, a new, high resolution capsule (ESO 2) with a larger field of view and better illumination than the previous CE has been introduced. A simplified ingestion protocol for CE that improves visualization of the Z-line has also been reported as well (17).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with known Barrett's Esophagus or chronic GERD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known Barrett's Esophagus or chronic GERD
Key inclusion criteria (4 listed)
- Patient age is 18 years or older
- Patient is known or suspected to suffer from an esophageal disease based on his/her medical history and recent symptoms suggestive of GERD or BE
- Patient agrees and signs the Informed Consent Form
- Currently taking PPI for at least 28 days.
Key exclusion criteria (15 listed)
- Patient has dysphagia
- Patient has known Zenker's Diverticulum
- Patient is known or is suspected to suffer from esophageal and/or intestinal obstruction
- Patient has a cardiac pacemakers or other implanted electro medical devices
- Patient who has undergone an EGD within past seven days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard.
Time frame: 7 days
3 secondary outcomes
Level of agreement (i.e. positive, negative and overall agreement parameters) between PillCam ESO 2 and standard EGD in classifying the Z-line following the ZAP score (Wallner et. al 2002), where Grades 0&I and grades II&III will be consolidated.
Time frame: 7 days
Accuracy Parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting Esophagitis as compared to standard EGD, using unblinded EGD as the reference standard.
Time frame: 7 days
Subjects' satisfaction will be assessed by a post procedure questionnaire
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Glen Eisen, MD principal investigator
Oregon Health and Science University
Prateek Sharma, MD principal investigator
Department of VA Medical Affairs Medical Center of Kansas City
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease, run by Medtronic - MITG at 10 sites in United States.
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 4 inclusion and 15 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: finished, 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 10 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard. (time frame: 7 days). 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; AzTrials last refreshed its copy on 26 Oct 2026.