Gastro Esophageal RefluxNCT03228407
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
A study testing Confocal endomicroscopy, Endoscopic biopsies and Mucosal impedance (MI) in people with Gastro Esophageal Reflux and Barrett Esophagus, run by McGuire Research Institute at 1 site in United States.
Trial summary
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux, Barrett Esophagus, Erosive Esophagitis
- What is being tested?
- Confocal endomicroscopy, Endoscopic biopsies and Mucosal impedance (MI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2017to Jun 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Ability to give informed consent
Who cannot join
- Pregnancy
- Esophageal varices
- Prior esophageal or gastric surgery
- Active gastrointestinal bleeding
- Evidence of esophageal malignancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Pritesh R Pritesh, MD,MPH, 804-675-5000 ext. 5021, pritesh.mutha@va.gov
Pritesh R Pritesh, MD,MPH
About this study
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
- Being tested
- Confocal endomicroscopy, Endoscopic biopsies, Mucosal impedance (MI)
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal endomicroscopyProcedure or surgery
Also called cellvizio
Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.
Endoscopic biopsiesDiagnostic test
Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.
Mucosal impedance (MI)Diagnostic test
MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Non-erosive reflux disease (NERD) | Active comparator | Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. Receives: Procedure: Confocal endomicroscopy; Diagnostic Test: Endoscopic biopsies; Diagnostic Test: Mucosal impedance (MI) |
| Barrett's esophagus/erosive esophagitis | Active comparator | Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. Receives: Procedure: Confocal endomicroscopy; Diagnostic Test: Endoscopic biopsies; Diagnostic Test: Mucosal impedance (MI) |
| Control | Placebo comparator | Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. Receives: Procedure: Confocal endomicroscopy; Diagnostic Test: Endoscopic biopsies; Diagnostic Test: Mucosal impedance (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) with esophageal permeability (i.e. - epithelial barrier function).
Measured: Through study completion, an average of 1 year.
Secondary outcomes (5)
Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with Barrett's esophagus and controls
Measured: Through study completion, an average of 1 year.
Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with symptoms of refractory GERD and Barrett's esophagus
Measured: Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and Barrett's esophagus
Measured: Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and controls
Measured: Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and Mucosal impedance findings of patients with symptoms of refractory GERD and controls
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start28 Apr 2017
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal RefluxStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGuire Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hunter Holmes McGuire VA Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228407
- Sponsor's protocol ID
- 2282
- Status last verified
- Jan 2018
- First submitted
- 6 Jul 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vaezi MF, Choksi Y. Mucosal Impedance: A New Way To Diagnose Reflux Disease and How It Could Change Your Practice. Am J Gastroenterol. 2017 Jan;112(1):4-7. doi: 10.1038/ajg.2016.513. Epub 2016 Dec 13. No abstract available.
PubMed 27958288Cui R, Zhou L, Lin S, Xue Y, Duan L, Xia Z, Jin Z, Zhang H, Zhang J, Song Z, Yan X. The feasibility of light microscopic measurements of intercellular spaces in squamous epithelium in the lower-esophagus of GERD patients. Dis Esophagus. 2011 Jan;24(1):1-5. doi: 10.1111/j.1442-2050.2010.01083.x.
PubMed 20626453Tobey NA, Carson JL, Alkiek RA, Orlando RC. Dilated intercellular spaces: a morphological feature of acid reflux--damaged human esophageal epithelium. Gastroenterology. 1996 Nov;111(5):1200-5. doi: 10.1053/gast.1996.v111.pm8898633.
PubMed 8898633Chu CL, Zhen YB, Lv GP, Li CQ, Li Z, Qi QQ, Gu XM, Yu T, Zhang TG, Zhou CJ, Rui-Ji, Li YQ. Microalterations of esophagus in patients with non-erosive reflux disease: in-vivo diagnosis by confocal laser endomicroscopy and its relationship with gastroesophageal reflux. Am J Gastroenterol. 2012 Jun;107(6):864-74. doi: 10.1038/ajg.2012.44. Epub 2012 Mar 13.
PubMed 22415199
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT03228407
- Acronym / sponsor ID
- 2282
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGuire Research InstituteUniversity, hospital or other
- Collaborators
- Hunter Holmes McGuire VA Medical Center
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 24 Jul 2017 (actual)
- 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.
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-erosive reflux disease (NERD) | Active comparator | Procedure: Confocal endomicroscopy, Diagnostic Test: Endoscopic biopsies, Diagnostic Test: Mucosal impedance (MI)Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. |
| Barrett's esophagus/erosive esophagitis | Active comparator | Procedure: Confocal endomicroscopy, Diagnostic Test: Endoscopic biopsies, Diagnostic Test: Mucosal impedance (MI)Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. |
| Control | Placebo comparator | Procedure: Confocal endomicroscopy, Diagnostic Test: Endoscopic biopsies, Diagnostic Test: Mucosal impedance (MI)Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Ability to give informed consent
Key exclusion criteria (6 listed)
- Pregnancy
- Esophageal varices
- Prior esophageal or gastric surgery
- Active gastrointestinal bleeding
- Evidence of esophageal malignancy
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 |
|---|---|---|
| Confocal endomicroscopyAlso: cellvizioConfocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined. | Procedure or surgery | Barrett's esophagus/erosive esophagitis, Control, Non-erosive reflux disease (NERD) |
| Endoscopic biopsiesAdditional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope. | Diagnostic test | Barrett's esophagus/erosive esophagitis, Control, Non-erosive reflux disease (NERD) |
| Mucosal impedance (MI)MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn. | Diagnostic test | Barrett's esophagus/erosive esophagitis, Control, Non-erosive reflux disease (NERD) |
Primary outcome
Correlation between the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) with esophageal permeability (i.e. - epithelial barrier function).
Time frame: Through study completion, an average of 1 year.
5 secondary outcomes
Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with Barrett's esophagus and controls
Time frame: Through study completion, an average of 1 year.
Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with symptoms of refractory GERD and Barrett's esophagus
Time frame: Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and Barrett's esophagus
Time frame: Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and controls
Time frame: Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and Mucosal impedance findings of patients with symptoms of refractory GERD and controls
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Background: PubMed 27958288Vaezi MF, Choksi Y. Mucosal Impedance: A New Way To Diagnose Reflux Disease and How It Could Change Your Practice. Am J Gastroenterol. 2017 Jan;112(1):4-7. doi: 10.1038/ajg.2016.513. Epub 2016 Dec 13. No abstract available.
- Results publication: PubMed 20626453Cui R, Zhou L, Lin S, Xue Y, Duan L, Xia Z, Jin Z, Zhang H, Zhang J, Song Z, Yan X. The feasibility of light microscopic measurements of intercellular spaces in squamous epithelium in the lower-esophagus of GERD patients. Dis Esophagus. 2011 Jan;24(1):1-5. doi: 10.1111/j.1442-2050.2010.01083.x.
- Results publication: PubMed 8898633Tobey NA, Carson JL, Alkiek RA, Orlando RC. Dilated intercellular spaces: a morphological feature of acid reflux--damaged human esophageal epithelium. Gastroenterology. 1996 Nov;111(5):1200-5. doi: 10.1053/gast.1996.v111.pm8898633.
- Results publication: PubMed 22415199Chu CL, Zhen YB, Lv GP, Li CQ, Li Z, Qi QQ, Gu XM, Yu T, Zhang TG, Zhou CJ, Rui-Ji, Li YQ. Microalterations of esophagus in patients with non-erosive reflux disease: in-vivo diagnosis by confocal laser endomicroscopy and its relationship with gastroesophageal reflux. Am J Gastroenterol. 2012 Jun;107(6):864-74. doi: 10.1038/ajg.2012.44. Epub 2012 Mar 13.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal endomicroscopy, Endoscopic biopsies and Mucosal impedance (MI) in people with Gastro Esophageal Reflux and Barrett Esophagus, run by McGuire Research Institute 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: status not confirmed, as of the sponsor's last update on 16 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pritesh R Mutha, MD,MPH (804-675-5000 ext. 5021, pritesh.mutha@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) with esophageal permeability (i.e. - epithelial barrier function). (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228407, which also lists 4 linked publications.
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 16 Jan 2018.