Barrett EsophagusEarly Phase 1NCT02606292
Photoacoustic Endoscopy of Barrett's Esophagus
A Early Phase 1 study testing Photoacoustic endoscopy in people with Barrett Esophagus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Photoacoustic endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2016
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and older.
- Patients with Barrett's esophagus scheduled for esophageal surgery.
- Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
- Subjects must be able to understand and willing to sign a written informed consent form.
Who cannot join
- Inability to give informed consent.
- Pregnancy.
- Age less than 18 years
- Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
- Acute GI bleeding.
- Coagulopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues.
The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.
- Conditions
- Barrett Esophagus
- Being tested
- Photoacoustic endoscopy, Endoscopic ultrasound (standard of care), Endoscopic surgery (standard of care)
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic endoscopyProcedure or surgery
Also called PAE
Endoscopic ultrasound (standard of care)Procedure or surgery
Also called EUS
Endoscopic surgery (standard of care)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: PAE assessment | Experimental | -The PAE-EUS assessment will be performed in the operating room by the after induction of general anesthesia and following strict sterile technique while the patient is being positioned and prepped for esophageal surgery. Receives: Procedure: Photoacoustic endoscopy; Procedure: Endoscopic ultrasound (standard of care); Procedure: Endoscopic surgery (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium
-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
Measured: Day 1
Sensitivity and specificity of PA endoscopic imaging for identification of Barrett's epithelium compared to esophageal biopsy
-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryan F Meyers, M.D., M.P.H., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606292
- Sponsor's protocol ID
- 201204145
- Status last verified
- Sep 2016
- First submitted
- 9 Nov 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoacoustic Endoscopy of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT02606292
- Acronym / sponsor ID
- 201204145
- Conditions
- Barrett Esophagus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Nov 2015 (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.
Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues.
The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: PAE assessment | Experimental | Procedure: Photoacoustic endoscopy, Procedure: Endoscopic ultrasound (standard of care), Procedure: Endoscopic surgery (standard of care)-The PAE-EUS assessment will be performed in the operating room by the after induction of general anesthesia and following strict sterile technique while the patient is being positioned and prepped for esophageal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years and older.
- Patients with Barrett's esophagus scheduled for esophageal surgery.
- Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
- Subjects must be able to understand and willing to sign a written informed consent form.
Key exclusion criteria (6 listed)
- Inability to give informed consent.
- Pregnancy.
- Age less than 18 years
- Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
- Acute GI bleeding.
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 |
|---|---|---|
| Photoacoustic endoscopyAlso: PAE | Procedure or surgery | Arm 1: PAE assessment |
| Endoscopic ultrasound (standard of care)Also: EUS | Procedure or surgery | Arm 1: PAE assessment |
| Endoscopic surgery (standard of care) | Procedure or surgery | Arm 1: PAE assessment |
Primary outcome
Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium
Time frame: Day 1
-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
Sensitivity and specificity of PA endoscopic imaging for identification of Barrett's epithelium compared to esophageal biopsy
Time frame: Day 1
-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
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 29 Sep 2016.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Bryan F Meyers, M.D., M.P.H. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Photoacoustic endoscopy in people with Barrett Esophagus, run by Washington University School of Medicine 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 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 29 Sep 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium (time frame: Day 1). The study lists 2 primary outcomes in all. 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 29 Sep 2016.