PEI-514VX 3D TEE Transducer Clinical Trial
Overview
Tab Title Description
Study type
ObservationalDescribes 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
- Rochester, Minnesota: 24-000981
Sponsor Protocol Number: DTM30-01698EN
About this study
The purpose of this study is to evaluate the safe use of the PEI-514VX 3D TEE transducer, while providing 2D or 3D cardiac images of diagnostic quality, to complete a TEE study.
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:
- Patients scheduled to undergo a TEE procedure.
- Male and female patients ages 18 and above in the following BMI categories.
- (Group 1) healthy weight ( BMI < 25) **** 6 patients (3 males and 3 females);
- (Group 2) overweight (25 ≤ BMI < 30) **** 6 patients ( 3 males and 3 females);
- (Group 3) obesity (BMI ≥ 30) **** 6 patients (3 males and 3 females).
- Informed consent understood and signed.
- The patient will comply with post-treatment follow-up protocol requirements.
Exclusion Criteria:
- Patients who do not meet the criteria described in 4.1.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/25/24. Questions regarding updates should be directed to the study team contact.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Sunil Mankad, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available