Actively Recruiting
Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
Led by Orlando Health, Inc. · Updated on 2024-04-01
140
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the standard echoendoscope with a newly developed device called the EndoSound Visual System to evaluate lesions in the gastrointestinal tract. This trial focuses on improving endoscopic ultrasound (EUS) examinations, which are commonly used to assess and biopsy lesions in the pancreas, bile duct, lymph nodes, and gastrointestinal tract due to their high sensitivity and accuracy. Participants will undergo EUS examinations using either the standard echoendoscope or the EndoSound Visual System, which attaches externally to a standard endoscope to convert it into an echoendoscope. Each participant will be randomly assigned to one of these two groups, and the EUS procedure will be performed according to standard care practices. During the study, researchers will assess the success rate of completing the EUS examination, ease of device maneuverability, imaging quality, tissue sampling performance, diagnostic adequacy and accuracy of specimens, procedure duration, procedure-related side effects, and costs. These evaluations will take place within one to seven days after the procedure. The total study participation timeline varies by participant based on scheduled assessments and follow-ups.
CONDITIONS
Brief Title
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 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
You will not qualify if you...
- Age under 18 years
- Unable to obtain consent for the procedure from either the patient or legally authorized representative
- Intrauterine pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo endoscopic ultrasound examination using either the Standard echoendoscope or the EndoSound Vision System to evaluate lesions in the gastrointestinal tract.
1 visit (in-person)
Duration - 7 days
Participants are monitored for procedure-related outcomes including diagnostic adequacy, accuracy, adverse events, and procedure costs.
Follow-up assessments up to 7 days after the procedure
Trial Site Locations
Total: 1 location
1
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
Research Team
J
Ji Young Bang, MD MPH
B
Barbara Broome
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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