Acid Reflux DiseaseNCT00588939
Confocal Laser Microscopy in Non Erosive Reflux Disease
An observational study of Acid Reflux Disease and Heartburn, run by Mayo Clinic at 1 site in United States.
Trial summary
Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acid Reflux Disease, Heartburn
- What is being tested?
- Cell~vizio (Laser connfocal microscopy)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: age 18 - 65 years symptoms of acid reflux disease
Who may be able to join
- Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease
- Patients who are able to give informed consent
Who cannot join
- Patients with a history of Erosive esophagitis
- Patients with a history of Barrett's esophagus
- Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices
- Patients who are unable or unwilling to undergo endoscopic evaluation
- Patients who are unable to give informed consent
- Patients with a known coagulopathy who are unable to be off therapy
Trial locations and contacts
1 site in 1 country.
About this study
Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this study is to identify the use of this new technique in diagnosing reflux in patients who have normal appearing esophagus.
Read the detailed description
Gastroesophageal reflux disease (GERD) remains a major problem in the United States affecting about 20% of Americans. Upper endoscopy (EGD) is commonly used to diagnose and grade GERD based on mucosal breaks and erosions. It is now evident from multiple studies however that the majority of GERD patients (50-70%) have negative EGDs.These patients are refered to as "Non Erosive Reflux Disease" (NERD) patients.Confocal Laser Microscopy (CLM) is a new endoscopic technique that offers the advantage of detecting histologic changes during real time endoscopy and thus can diagnose NERD. We thus propose to study the sensitivity and specificity of CLM in predicting NERD. We hypothesize that CLM can reliably diagnose NERD in the appropriate clinical setting based on intrapapillary capillary loop patterns. This will be a pilot study after which a randomized trial will evaluate the reversibility of these changes after PPI therapy as seen by CLM
- Conditions
- Acid Reflux Disease, Heartburn
- Being tested
- Cell~vizio (Laser connfocal microscopy)
- Keywords
- reflux, heartburn
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell~vizio (Laser connfocal microscopy)Device
Also called Mauna Kea Cellvizeo
completed during endoscopy
| Study group | Role | What they receive |
|---|---|---|
| I | participants with symptoms of acid reflux disease (heartburn) Receives: Device: Cell~vizio (Laser connfocal microscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD
Measured: at time of procedure
Secondary outcomes (1)
To assess the additional charges of implementing CLM in EGD
Measured: at time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth K. Wang, Mayo Clinic
- Investigators
- Kenneth K Wang, MD, Study director, Mayo ClinicRami Badreddine, MD, Principal investigator, Malyo Clinic Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588939
- Sponsor's protocol ID
- 07-006186
- Status last verified
- May 2013
- First submitted
- 22 Dec 2007
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Microscopy in Non Erosive Reflux Disease
- ClinicalTrials.gov ID
- NCT00588939
- Acronym / sponsor ID
- 07-006186
- Conditions
- Acid Reflux Disease, Heartburn
- Keywords
- reflux, heartburn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Jan 2008 (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.
Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this study is to identify the use of this new technique in diagnosing reflux in patients who have normal appearing esophagus.
Detailed description
Gastroesophageal reflux disease (GERD) remains a major problem in the United States affecting about 20% of Americans. Upper endoscopy (EGD) is commonly used to diagnose and grade GERD based on mucosal breaks and erosions. It is now evident from multiple studies however that the majority of GERD patients (50-70%) have negative EGDs.These patients are refered to as "Non Erosive Reflux Disease" (NERD) patients.Confocal Laser Microscopy (CLM) is a new endoscopic technique that offers the advantage of detecting histologic changes during real time endoscopy and thus can diagnose NERD. We thus propose to study the sensitivity and specificity of CLM in predicting NERD. We hypothesize that CLM can reliably diagnose NERD in the appropriate clinical setting based on intrapapillary capillary loop patterns. This will be a pilot study after which a randomized trial will evaluate the reversibility of these changes after PPI therapy as seen by CLM
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | Device: Cell~vizio (Laser connfocal microscopy)participants with symptoms of acid reflux disease (heartburn) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- age 18 - 65 years symptoms of acid reflux disease
Key inclusion criteria (2 listed)
- Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease
- Patients who are able to give informed consent
Key exclusion criteria (6 listed)
- Patients with a history of Erosive esophagitis
- Patients with a history of Barrett's esophagus
- Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices
- Patients who are unable or unwilling to undergo endoscopic evaluation
- Patients who are unable to give informed consent
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 |
|---|---|---|
| Cell~vizio (Laser connfocal microscopy)Also: Mauna Kea Cellvizeocompleted during endoscopy | Device | I |
Primary outcome
To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD
Time frame: at time of procedure
1 secondary outcome
To assess the additional charges of implementing CLM in EGD
Time frame: at time of procedure
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 21 May 2013.
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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.
Kenneth K Wang, MD study director
Mayo Clinic
Rami Badreddine, MD principal investigator
Malyo Clinic Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acid Reflux Disease and Heartburn, run by Mayo Clinic at 1 site 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 2 inclusion and 6 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 21 May 2013. 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 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?
To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD (time frame: at time of procedure). 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 21 May 2013.