Barrett's EsophagusNCT00588575
Ramanspectroscopy in Barrett's Esophagus
An observational study of Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to see if a new device, called near-infrared Raman spectroscopy, can provide similar information as that obtained from taking biopsies of the lining of your Barrett's esophagus Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Oct 2007
- 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: Barrett's esophagus surveillance
Who may be able to join
- Closed to further enrollment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-Vivo Raman Spectroscopy of Barrett's Esophagus
This study is being done to see if a new device, called near-infrared Raman spectroscopy, can provide similar information as that obtained from taking biopsies of the lining of your Barrett's esophagus
Read the detailed description
In the search for means to enhance the surveillance of BE, optical spectroscopy is emerging as a candidate with high potential. Optical spectroscopic techniques measure specific light-tissue interactions, such as fluorescence, elastic scattering, and Raman (inelastic) scattering, which provide objective and quantitative diagnostic information about the molecular and/or structural status of tissue. Moreover, optical spectroscopy has the capacity to identify tissue pathology in situ in a rapid and non-destructive fashion. Among the optical spectroscopic techniques, near-infrared Raman spectroscopy (NIRS) is particularly promising because of the wealth of molecular-specific information contained in its spectra
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startOct 2004
- Primary completionMay 2007
- Study completionOct 2007
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Louis-Michel Wong Kee Song, Mayo Clinic
- Investigators
- Louis M Wongkeesong, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588575
- Sponsor's protocol ID
- 1999-04 00
- Other IDs
- DK67148, Raman
- Status last verified
- Sep 2009
- First submitted
- 22 Dec 2007
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Raman Spectroscopy of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT00588575
- Acronym / sponsor ID
- 1999-04 00
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 8 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.
This study is being done to see if a new device, called near-infrared Raman spectroscopy, can provide similar information as that obtained from taking biopsies of the lining of your Barrett's esophagus
Detailed description
In the search for means to enhance the surveillance of BE, optical spectroscopy is emerging as a candidate with high potential. Optical spectroscopic techniques measure specific light-tissue interactions, such as fluorescence, elastic scattering, and Raman (inelastic) scattering, which provide objective and quantitative diagnostic information about the molecular and/or structural status of tissue. Moreover, optical spectroscopy has the capacity to identify tissue pathology in situ in a rapid and non-destructive fashion. Among the optical spectroscopic techniques, near-infrared Raman spectroscopy (NIRS) is particularly promising because of the wealth of molecular-specific information contained in its spectra
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Barrett's esophagus surveillance
Key inclusion criteria (1 listed)
- Closed to further enrollment
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 11 Dec 2019.
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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.
Louis M Wongkeesong, 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?
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 1 inclusion and 0 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 11 Dec 2019. 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.
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 11 Dec 2019.