Barrett's EsophagusNCT01401699
Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
A study testing Optical Frequency Domain Imaging (OFDI) in people with Barrett's Esophagus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Optical Frequency Domain Imaging (OFDI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to 16 Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- over the age of 18,
- capable of giving informed consent,
- are undergoing elective EGD, and
- if female are willing to take a pregnancy test
Who cannot join
- patients on oral anticoagulation medications,
- with a history of hemostasis disorders and
- patients that are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachussetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction
The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .
Read the detailed description
Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD) procedures will be recruited for examination at the gastroesophageal junction with our developed OCT imaging system. The patients will undergo a clinical EGD procedure including endoscopic biopsy. The first step in the procedure follows the standard care with the performance of the surveillance endoscopy. The study experimental procedure will then begin. This study requires the use of a balloon . The balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in place, and the OCT balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and will remain in this fixed position throughout the entire procedure. Once the OCT imaging probe is in place, OCT image data will be continuously collected over the length of the balloon(approximately 5 cm).
It is expected that the total examination time including insertion and inflation of the OCT balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the total length of the EGD.
- Conditions
- Barrett's Esophagus
- Being tested
- Optical Frequency Domain Imaging (OFDI)
- Keywords
- Barrett's, esophagus, OCT, imaging
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Frequency Domain Imaging (OFDI)Device
Optical Frequency Domain (OFDI) imaging of esophagus
| Study group | Role | What they receive |
|---|---|---|
| Optical Frequency Domain imaging System | Experimental | Optical Frequency Domain Imaging (OFDI) balloon based imaging Receives: Device: Optical Frequency Domain Imaging (OFDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.
Measured: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startSep 2006
- Primary completion16 Nov 2011
- Study completion16 Nov 2011
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.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, MD PhD, Principal investigator, Massachussetts General HospitalNorman Nishioka, MD, Principal investigator, Massachussetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401699
- Sponsor's protocol ID
- 2006-P-000203
- Other IDs
- 5R21CA141884
- Status last verified
- Jan 2023
- First submitted
- 20 Jul 2011
- Last updated
- 18 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
- Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT01401699
- Acronym / sponsor ID
- 2006-P-000203
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's, esophagus, OCT, imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2006
- Primary completion
- 16 Nov 2011 (actual)
- Study completion
- 16 Nov 2011 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 28 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .
Detailed description
Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD) procedures will be recruited for examination at the gastroesophageal junction with our developed OCT imaging system. The patients will undergo a clinical EGD procedure including endoscopic biopsy. The first step in the procedure follows the standard care with the performance of the surveillance endoscopy. The study experimental procedure will then begin. This study requires the use of a balloon . The balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in place, and the OCT balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and will remain in this fixed position throughout the entire procedure. Once the OCT imaging probe is in place, OCT image data will be continuously collected over the length of the balloon(approximately 5 cm).
It is expected that the total examination time including insertion and inflation of the OCT balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the total length of the EGD.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Frequency Domain imaging System | Experimental | Device: Optical Frequency Domain Imaging (OFDI)Optical Frequency Domain Imaging (OFDI) balloon based imaging |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- over the age of 18,
- capable of giving informed consent,
- are undergoing elective EGD, and
- if female are willing to take a pregnancy test
Key exclusion criteria (3 listed)
- patients on oral anticoagulation medications,
- with a history of hemostasis disorders and
- patients that are pregnant
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 |
|---|---|---|
| Optical Frequency Domain Imaging (OFDI)Optical Frequency Domain (OFDI) imaging of esophagus | Device | Optical Frequency Domain imaging System |
Primary outcome
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
Time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Guillermo Tearney, MD PhD principal investigator
Massachussetts General Hospital
Norman Nishioka, MD principal investigator
Massachussetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Frequency Domain Imaging (OFDI) in people with Barrett's Esophagus, run by Massachusetts General Hospital 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 4 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 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 28 Sep 2018). 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?
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening (time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes). 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.