NCT07321925 Thermoacoustic Method for Estimating Liver Fat Fraction
| NCT ID | NCT07321925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Endra Lifesciences |
| Condition | MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 49 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 49 participants in total. It began in 2025-08-15 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. The goal is to create a more accessible device to measure liver fat as it is an indicator for overall health and metabolic diseases.
Eligibility Criteria
Inclusion Criteria: * Study participants are 18 or older. * Able to understand, read, and provide written informed consent in English. * Able to tolerate both ultrasound and MRI examinations. * Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds. Exclusion Criteria: * Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI. * Known pregnancy the day of consent or becoming pregnant during study participation based on start date of last menstrual period). * Liver diseases other than MASLD/MASH/fibrosis including, but not limited to: * Cirrhosis * Hepatocellular carcinoma * Ascites * Patients with broken, or injured skin, in the right upper abdominal quadrant. * Body habitus, or anatomical variation, where the liver capsule is not accessible with ultrasound through the patient's right intercostal imaging window used in conventional ultrasound liver imaging. * BMI greater than 50 kg/m2 * Patients with subcutaneous fat at measurement location less than or equal to 6mm. * Patients with a missing liver lobe. * Patients with peri-hepatic fat in the measurement location. * Patients with focal liver lesions or anatomical structures in the measurement location, as detected by ultrasound.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07321925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07321925 currently recruiting?
Yes, NCT07321925 is actively recruiting participants. Contact the research team at zrouag@endrainc.com for enrollment information.
Where is the NCT07321925 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07321925 clinical trial?
NCT07321925 is sponsored by Endra Lifesciences. The trial plans to enroll 49 participants.