Barrett's Esophagus With DysplasiaNCT03077594
Characterization of the Neo-squamous Epithelial Barrier
An observational study of Barrett's Esophagus With Dysplasia, run by Mayo Clinic at 2 sites in United States.
Trial summary
To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Barrett's Esophagus With Dysplasia
- What is being tested?
- Mucosal Impedance, Research Biopsies and Volumetric Laser Endomicroscopy
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2016to 29 Jun 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have successfully completed endoscopic ablation (one endoscopy with no evidence of intestinal metaplasia).
Who may be able to join
- Adults (age 18-90) who underwent an ablative program for BE
Who cannot join
- Patients that have not achieved complete remission of intestinal metaplasia.
- Patients unable to consent.
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus
To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related metaplasia.
Read the detailed description
The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia).
Mucosal impedance will be measured by an endoscopic probe. Research biopsies will also be obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.
Volumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous structures underneath the neosquamous epithelium.
- Conditions
- Barrett's Esophagus With Dysplasia
- Being tested
- Mucosal Impedance, Research Biopsies, Volumetric Laser Endomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosal ImpedanceDevice
Aim 1: Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Mucosal impedance will be measured 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.
Research BiopsiesOther
Aim 1: Research biopsies will be obtained at 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction, and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Aim 2: Research biopsies will be taken 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.
Volumetric Laser EndomicroscopyDevice
Aim 2: Volumetric laser endomicroscopy will be done and marked at 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.
| Study group | Role | What they receive |
|---|---|---|
| Successfully ablated patients | Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Receives: Device: Mucosal Impedance; Other: Research Biopsies | |
| Successfully ablated patients - VLE | Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Volumetric laser endomicroscopy (VLE) will be done. Receives: Device: Mucosal Impedance; Other: Research Biopsies; Device: Volumetric Laser Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Impedance as measured by an endoscopic probe
Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.
Measured: Up to two years
Secondary outcomes (3)
Tissue levels of prostaglandin E2
Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.
Measured: Up to two years
Intracellular space
Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.
Measured: Up to two years
Volumetric Laser Endomicroscopy
Assess and measure precise thickness of and area of subsquamous structions underneath the neosquamous epithelium.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start26 Sep 2016
- Primary completion1 Nov 2019
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's Esophagus With DysplasiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasad G. Iyer, Mayo Clinic
- Investigators
- Prasad Iyer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077594
- Sponsor's protocol ID
- 16-005490
- Status last verified
- Jan 2023
- First submitted
- 1 Feb 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT03077594
- Acronym / sponsor ID
- 16-005490
- Conditions
- Barrett's Esophagus With Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 13 Mar 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.
To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related metaplasia.
Detailed description
The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia).
Mucosal impedance will be measured by an endoscopic probe. Research biopsies will also be obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.
Volumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous structures underneath the neosquamous epithelium.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successfully ablated patients | – | Device: Mucosal Impedance, Other: Research BiopsiesMucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. |
| Successfully ablated patients - VLE | – | Device: Mucosal Impedance, Other: Research Biopsies, Device: Volumetric Laser EndomicroscopyMucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Volumetric laser endomicroscopy (VLE) will be done. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have successfully completed endoscopic ablation (one endoscopy with no evidence of intestinal metaplasia).
Key inclusion criteria (1 listed)
- Adults (age 18-90) who underwent an ablative program for BE
Key exclusion criteria (3 listed)
- Patients that have not achieved complete remission of intestinal metaplasia.
- Patients unable to consent.
- Pregnant women
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 |
|---|---|---|
| Mucosal ImpedanceAim 1: Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Mucosal impedance will be measured 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction. | Device | Successfully ablated patients, Successfully ablated patients - VLE |
| Research BiopsiesAim 1: Research biopsies will be obtained at 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction, and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Aim 2: Research biopsies will be taken 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction. | Other | Successfully ablated patients, Successfully ablated patients - VLE |
| Volumetric Laser EndomicroscopyAim 2: Volumetric laser endomicroscopy will be done and marked at 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction. | Device | Successfully ablated patients - VLE |
Primary outcome
Mucosal Impedance as measured by an endoscopic probe
Time frame: Up to two years
Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.
3 secondary outcomes
Tissue levels of prostaglandin E2
Time frame: Up to two years
Intracellular space
Time frame: Up to two years
Volumetric Laser Endomicroscopy
Time frame: Up to two years
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 18 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Prasad Iyer, MD principal investigator
Mayo Clinic
2 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 With Dysplasia, run by Mayo Clinic at 2 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 1 inclusion and 3 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 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Mucosal Impedance as measured by an endoscopic probe (time frame: Up to two years). 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 18 Jan 2023.