Barrett's EsophagusEIBS in BENCT01188980
Early Increase in Blood Supply in Patients With Barrett's Esophagus
An observational study of Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if early Barrett's specialized intestinal metaplasia can be detected by measuring early increased blood supply of the esophageal tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in real time. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2013
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Control Population: Patients with no Barrett's metaplasia scheduled for upper endoscopy at Mayo Clinic Jacksonville. Experimental Population: Patients with biopsy-proven Barrett's esophagus and previously scheduled for upper endoscopy at Mayo Clinic Jacksonville.
Who may be able to join
- age 18 years or older,
- informed written consent,
- patient scheduled for previously planned upper endoscopy
Who cannot join
- liver disease;
- gastric antral vascular ectasia (GAVE);any known non-esophageal aerodigestive malignancy;
- severe cardiopulmonary disease precluding endoscopy; presence of conditions not allowing biopsy (e.g. coagulation disorder);
- known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc.);
- known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detectable Esophageal Early Increase in Blood Supply (EIBS) in Patients With Barrett's Esophagus
The purpose of this study is to determine if early Barrett's specialized intestinal metaplasia can be detected by measuring early increased blood supply of the esophageal tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in real time.
- Conditions
- Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus
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 |
|---|---|---|
| NoBE (control) | Not described | |
| BE without dysplasia | Not described | |
| BE with dysplasia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine if early increase blood supply (EIBS)can predict presence of Dysplasia
To determine if early increase blood supply (EIBS), as measured in Barrett's glandular mucosa segment, can predict the presence of Dysplasia in patients with known diagnosis of Barrett's esophagus (BE).
Measured: 10 minutes during standard upper endoscopy
Secondary outcomes (1)
determine if EIBS can predict presence of BE in patients undergoing upper endoscopy
EIBS measurements taken from buccal mucosa and esophagus will be compared in patients without BE, patients with BE without dysplasia, and patients with BE dysplasia. EIBS measurements will be obtained from normal squamous mucosa in the mouth, proximal esophagus, areas of BE in the distal esophagus, and measurements from the gastric cardia/hiatal hernia (at least 4 cm below the Z line.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionApr 2013
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.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herbert C. Wolfsen, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188980
- Sponsor's protocol ID
- 09-005328
- Acronym
- EIBS in BE
- Status last verified
- Apr 2016
- First submitted
- 24 Aug 2010
- Last updated
- 22 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detectable Esophageal Early Increase in Blood Supply (EIBS) in Patients With Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT01188980
- Acronym / sponsor ID
- EIBS in BE / 09-005328
- Conditions
- Barrett's Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Aug 2010 (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.
The purpose of this study is to determine if early Barrett's specialized intestinal metaplasia can be detected by measuring early increased blood supply of the esophageal tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in real time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NoBE (control) | – | – |
| BE without dysplasia | – | – |
| BE with dysplasia | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Control Population: Patients with no Barrett's metaplasia scheduled for upper endoscopy at Mayo Clinic Jacksonville. Experimental Population: Patients with biopsy-proven Barrett's esophagus and previously scheduled for upper endoscopy at Mayo Clinic Jacksonville.
Key inclusion criteria (3 listed)
- age 18 years or older,
- informed written consent,
- patient scheduled for previously planned upper endoscopy
Key exclusion criteria (5 listed)
- liver disease;
- gastric antral vascular ectasia (GAVE);any known non-esophageal aerodigestive malignancy;
- severe cardiopulmonary disease precluding endoscopy; presence of conditions not allowing biopsy (e.g. coagulation disorder);
- known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc.);
- known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.
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
determine if early increase blood supply (EIBS)can predict presence of Dysplasia
Time frame: 10 minutes during standard upper endoscopy
To determine if early increase blood supply (EIBS), as measured in Barrett's glandular mucosa segment, can predict the presence of Dysplasia in patients with known diagnosis of Barrett's esophagus (BE).
1 secondary outcome
determine if EIBS can predict presence of BE in patients undergoing upper endoscopy
Time frame: 10 minutes
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 22 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 3 inclusion and 5 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 22 Apr 2016. 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?
determine if early increase blood supply (EIBS)can predict presence of Dysplasia (time frame: 10 minutes during standard upper endoscopy). 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 22 Apr 2016.