Barrett's EsophagusNCT02066233
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
A study testing EG Scan II (transnasal endoscopy) and Standard Endoscopy in people with Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- EG Scan II (transnasal endoscopy) and Standard Endoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia.
- Able and willing to give informed consent.
Who cannot join
- Patients known to be intolerant to endoscopy.
- Patients with frequent epistaxis.
- Patients not clinically fit for endoscopy as judged by their care team.
- Pregnant women.
- Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex)
- Use of anticoagulants or antiplatelets.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy.
Read the detailed description
All subjects underwent two procedures: the E.G.Scan II followed by standard endoscopy in a tandem design. The E.G. Scan II is a transnasal endoscope system to capture and transmit images of the esophagus. Captured images can be reviewed via the E.G. View for diagnosis of diseases related to the esophagus. Generally, the commercial esophagoscope system has reusable probes, but E.G. Scan™ II has a single use probe because reusable probes have the risk of infection and pollution.
Prior to the E.G.Scan, subjects received a standard prep for the procedure. The two procedures were performed by two different experienced endoscopists who were blinded to the indication of the procedure. At both procedures a note was made of any abnormality of the esophagus. Every subject with an endoscopic diagnosis of Barrett's Esophagus had clinical biopsies taken to confirm diagnosis. Subject tolerability was measured with a 10-point visual analog scale (VAS) where 0 represented the "worst experience" and 10 the "best experience."
- Conditions
- Barrett's Esophagus
- Being tested
- EG Scan II (transnasal endoscopy), Standard Endoscopy
- Keywords
- Barrett's, esophagus, reflux, heartburn, screening
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG Scan II (transnasal endoscopy)Device
Standard EndoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Barrett's Esophagus | Active comparator | All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy. Receives: Device: EG Scan II (transnasal endoscopy); Procedure: Standard Endoscopy |
| Subjects with Reflux and/or Heartburn | Active comparator | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. Receives: Device: EG Scan II (transnasal endoscopy); Procedure: Standard Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Tolerability Score on 10-point Visual Analog Scale (VAS)
On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."
Measured: Within 48 hours
Secondary outcomes (1)
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy
Subjects were asked the following question: "Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future?" Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- IntroMedic Co., Ltd.
- Responsible party
- Principal investigator, Prasad G. Iyer, Mayo Clinic
- Investigators
- Prasad G Iyer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066233
- Sponsor's protocol ID
- 13-008214
- Status last verified
- Jun 2017
- First submitted
- 3 Feb 2014
- Last updated
- 6 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sami SS, Iyer PG, Pophali P, Halland M, di Pietro M, Ortiz-Fernandez-Sordo J, White JR, Johnson M, Guha IN, Fitzgerald RC, Ragunath K. Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. Clin Gastroenterol Hepatol. 2019 Mar;17(4):638-646.e1. doi: 10.1016/j.cgh.2018.07.019. Epub 2018 Aug 3.
PubMed 30081223
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
- ClinicalTrials.gov ID
- NCT02066233
- Acronym / sponsor ID
- 13-008214
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's, esophagus, reflux, heartburn, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- IntroMedic Co., Ltd.
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 6 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy.
Detailed description
All subjects underwent two procedures: the E.G.Scan II followed by standard endoscopy in a tandem design. The E.G. Scan II is a transnasal endoscope system to capture and transmit images of the esophagus. Captured images can be reviewed via the E.G. View for diagnosis of diseases related to the esophagus. Generally, the commercial esophagoscope system has reusable probes, but E.G. Scan™ II has a single use probe because reusable probes have the risk of infection and pollution.
Prior to the E.G.Scan, subjects received a standard prep for the procedure. The two procedures were performed by two different experienced endoscopists who were blinded to the indication of the procedure. At both procedures a note was made of any abnormality of the esophagus. Every subject with an endoscopic diagnosis of Barrett's Esophagus had clinical biopsies taken to confirm diagnosis. Subject tolerability was measured with a 10-point visual analog scale (VAS) where 0 represented the "worst experience" and 10 the "best experience."
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Barrett's Esophagus | Active comparator | Device: EG Scan II (transnasal endoscopy), Procedure: Standard EndoscopyAll subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy. |
| Subjects with Reflux and/or Heartburn | Active comparator | Device: EG Scan II (transnasal endoscopy), Procedure: Standard EndoscopyAll subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia.
- Able and willing to give informed consent.
Key exclusion criteria (6 listed)
- Patients known to be intolerant to endoscopy.
- Patients with frequent epistaxis.
- Patients not clinically fit for endoscopy as judged by their care team.
- Pregnant women.
- Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex)
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 |
|---|---|---|
| EG Scan II (transnasal endoscopy) | Device | Subjects with Barrett's Esophagus, Subjects with Reflux and/or Heartburn |
| Standard Endoscopy | Procedure or surgery | Subjects with Barrett's Esophagus, Subjects with Reflux and/or Heartburn |
Primary outcome
Median Tolerability Score on 10-point Visual Analog Scale (VAS)
Time frame: Within 48 hours
On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."
1 secondary outcome
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy
Time frame: Two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30081223Sami SS, Iyer PG, Pophali P, Halland M, di Pietro M, Ortiz-Fernandez-Sordo J, White JR, Johnson M, Guha IN, Fitzgerald RC, Ragunath K. Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. Clin Gastroenterol Hepatol. 2019 Mar;17(4):638-646.e1. doi: 10.1016/j.cgh.2018.07.019. Epub 2018 Aug 3.
- 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 G Iyer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EG Scan II (transnasal endoscopy) and Standard Endoscopy in people with Barrett's Esophagus, 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 6 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Tolerability Score on 10-point Visual Analog Scale (VAS) (time frame: Within 48 hours). 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 NCT02066233, which also lists 1 linked publication.
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 6 Jul 2017.