Recruiting

Thermoacoustic Ultrasound

Sponsor:

Endra Lifesciences

Code:

NCT07321925

Conditions

MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Fatty Liver Disease, Nonalcoholic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Thermoacoustic Enhanced Ultrasound

Study Details

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.

Conditions

MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Fatty Liver Disease, Nonalcoholic

Study ID

NCT07321925

Start date

Aug 15, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Oct 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

49 participants

Anticipated

Interventions and Outcome Measures

Interventions

Thermoacoustic Enhanced Ultrasound

a novel Thermoacoustic Enhanced imaging device

Primary outcome measure

  • Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF [ Time Frame: From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received. ]

Central Contacts and Locations

Central contacts

Ziad Rouag

415-531-4647zrouag@endrainc.com

Ava Ohlgren

734-315-0090aohlgren@endrainc.com

Locations

ENDRA Life Sciences

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Ava Ohlgren

734-210-0129aohlgren@endrainc.com

Chris Bull

734-210-0129cbull@endrainc.com

More Information

Sponsor

Endra Lifesciences

Last update posted

Jan 7, 2026

Last verified

Dec, 2025

Keywords

  • Fatty Liver
  • MASLD
  • MASH
  • Thermoacoustic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Endra Lifesciences on 2026-01-07.