Comparing two methods for examining gastrointestinal lesions
Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
This study is testing whether a new imaging system for examining gastrointestinal lesions works better than the standard method for people undergoing endoscopic ultrasound.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Orlando Health, Inc. Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06340620 on ClinicalTrials.gov |
What this trial studies
This trial compares the standard echoendoscope with the newly developed EndoSound Visual System for evaluating lesions in the gastrointestinal tract. Endoscopic ultrasound (EUS) is a key procedure for diagnosing pancreatic and bile duct diseases, and this study aims to assess whether the EndoSound Visual System offers advantages over traditional methods. Participants will be randomly assigned to receive either the standard or the new system during their EUS examination. The goal is to determine which method provides better diagnostic accuracy and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require an EUS examination for various gastrointestinal conditions.
Not a fit: Patients under 18 years old or those unable to consent for the procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic capabilities for patients with pancreatic and gastrointestinal diseases.
How similar studies have performed: While endoscopic ultrasound is a well-established technique, the specific application of the EndoSound Visual System is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Age \< 18 years. * Unable to obtain consent for the procedure from either the patient or LAR. * Intrauterine pregnancy.
Where this trial is running
Orlando, Florida
- Orlando Health — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ji Young Bang, MD MPH — Orlando Health, Digestive Health Institute
- Study coordinator: Ji Young Bang, MD MPH
- Email: jiyoung.bang@orlandohealth.com
- Phone: 321-841-2431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.