Pancreatic DiseaseNCT06340620
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
A study testing Endoscopic ultrasound examination in people with Pancreatic Disease and Pancreatic Cancer, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Disease, Pancreatic Cancer, Pancreatic Cyst
- What is being tested?
- Endoscopic ultrasound examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Any patient undergoing EUS examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon.
Who cannot join
- Age < 18 years.
- Unable to obtain consent for the procedure from either the patient or LAR.
- Intrauterine pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 32806
Ji Young Bang, MD MPH, 321-841-2431, jiyoung.bang@orlandohealth.com
Barbara Broome, 321-841-4356, barbara.broome@orlandohealth.com
About this study
Official title: Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
Read the detailed description
Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination.
The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
- Conditions
- Pancreatic Disease, Pancreatic Cancer, Pancreatic Cyst, Gastrointestinal Tumor, Bile Duct Diseases, Bile Duct Cancer
- Being tested
- Endoscopic ultrasound examination
- Keywords
- Endoscopic ultrasound, EndoSound Vision System, Randomized trial
- Medical subject headings
- Pancreatic Diseases, Pancreatic Neoplasms, Pancreatic Cyst, Digestive System Neoplasms, Bile Duct Diseases, Bile Duct Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound examinationDevice
Endoscopic ultrasound examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Standard echoendoscope | Active comparator | Standard echoendoscope will be used and EUS examination will be performed per standard of care. Receives: Device: Endoscopic ultrasound examination |
| EndoSound Vision System | Active comparator | EndoSound Vision System will be used and EUS examination will be performed per standard of care. Receives: Device: Endoscopic ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful completion of the requisite EUS examination
Rate of successful completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, compared as a percentage of successfully completed examinations between the standard echoendoscope and Endosound Vision System.
Measured: 1 day
Secondary outcomes (9)
Ease of maneuverability of the device
The ease of maneuverability during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to maneuver and 5 is the most difficult to maneuver).
Measured: 1 day
Quality of EUS imaging
The quality of EUS imaging during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the best quality imaging and 5 is the worst quality imaging).
Measured: 1 day
Ease of performing tissue acquisition
The ease of performing tissue acquisition during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to perform and 5 is the most difficult to perform).
Measured: 1 day
Diagnostic adequacy of procured specimen on onsite evaluation
Rate of diagnostic adequacy of procured tissue specimen on onsite evaluation between the EndoSound Vision System and standard echoendoscopes.
Measured: 7 days
Diagnostic adequacy of procured specimen in cell block
Rate of diagnostic adequacy of procured tissue specimen in cell block between the EndoSound Vision System and standard echoendoscopes.
Measured: 7 days
Diagnostic accuracy of procured specimen
Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes.
Measured: 7 days
Procedure duration
Duration of procedure between the EndoSound Vision System and standard echoendoscopes.
Measured: 1 day
Rate of procedure-related adverse events
Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes.
Measured: 7 days
Procedure costs
Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Young Bang, MD MPH, Principal investigator, Orlando Health, Digestive Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340620
- Sponsor's protocol ID
- 24.017.01
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
- ClinicalTrials.gov ID
- NCT06340620
- Acronym / sponsor ID
- 24.017.01
- Conditions
- Pancreatic Disease, Pancreatic Cancer, Pancreatic Cyst, Gastrointestinal Tumor, Bile Duct Diseases, Bile Duct Cancer
- Keywords
- Endoscopic ultrasound, EndoSound Vision System, Randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Apr 2024 (actual)
- 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 is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
Detailed description
Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination.
The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard echoendoscope | Active comparator | Device: Endoscopic ultrasound examinationStandard echoendoscope will be used and EUS examination will be performed per standard of care. |
| EndoSound Vision System | Active comparator | Device: Endoscopic ultrasound examinationEndoSound Vision System will be used and EUS examination will be performed per standard of care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Any patient undergoing EUS examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon.
Key exclusion criteria (3 listed)
- Age < 18 years.
- Unable to obtain consent for the procedure from either the patient or LAR.
- Intrauterine pregnancy.
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 |
|---|---|---|
| Endoscopic ultrasound examinationEndoscopic ultrasound examination will be performed. | Device | EndoSound Vision System, Standard echoendoscope |
Primary outcome
Rate of successful completion of the requisite EUS examination
Time frame: 1 day
Rate of successful completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, compared as a percentage of successfully completed examinations between the standard echoendoscope and Endosound Vision System.
9 secondary outcomes
Ease of maneuverability of the device
Time frame: 1 day
Quality of EUS imaging
Time frame: 1 day
Ease of performing tissue acquisition
Time frame: 1 day
Diagnostic adequacy of procured specimen on onsite evaluation
Time frame: 7 days
Diagnostic adequacy of procured specimen in cell block
Time frame: 7 days
Diagnostic accuracy of procured specimen
Time frame: 7 days
Procedure duration
Time frame: 1 day
Rate of procedure-related adverse events
Time frame: 7 days
Procedure costs
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
Ji Young Bang, MD MPH principal investigator
Orlando Health, Digestive Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound examination in people with Pancreatic Disease and Pancreatic Cancer, run by Orlando Health, Inc. 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 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Young Bang, MD MPH (321-841-2431, jiyoung.bang@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful completion of the requisite EUS examination (time frame: 1 day). 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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.