Study to Create a Registry to Collect the Findings and Outcomes of Patients Undergoing Contrast-Enhanced Harmonic Endoscopic Ultrasound (CE-EUS)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-008737
Sponsor Protocol Number: 18-008737
About this study
The purpose of this study is to describe the findings and outcomes of patient undergoing contrast-enhanced harmonic endoscopic ultrasound (CE-EUS) imaging. A registry will be created to monitor for possible procedure adverse events and to perform descriptive statistics for the patients who undergo this procedure.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male and female patients aged 18 years to 99 years old.
- Referred for endoscopic ultrasound.
- Based on clinical judgement of the advanced endoscopist, those who present with lesions where increased microvasculature and perfusion visualization with contrast-enhanced harmonic endoscopic ultrasound imaging would be of beneficial for lesion characterization.
- Patients with esophageal, pancreatic, liver or gastric tumors, or adenopathy are anticipated to possibly benefit from improved lesion vascularity visualization with contrast-enhanced harmonic endoscopic ultrasound Imaging when compared with standard EUS/Doppler imaging.
- Patients who cannot undergo contrast enhanced CT or MRI imaging due to renal failure or allergic reactions would benefit from this approach.
- Clinical medical stability to undergo sedation for endoscopy.
- Provide informed consent.
Exclusion Criteria:
- Medical condition that precludes the patient from having an endoscopic procedure.
- Patients who cannot provide adequate research authorization.
- Patients with known allergies to ultrasound contrast agents.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Michael Wallace, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available