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A painless spleen scan could spot deadly vein bleeding risk without endoscopy

NCT ID NCT07753577

Diagnosis Sponsor: Beijing Friendship Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether a new device, Pro9000X, can measure spleen stiffness to detect esophageal varices—enlarged veins in the esophagus that can bleed dangerously—in people with chronic liver disease. Currently, the only reliable way to diagnose these varices is an invasive endoscopy, which is uncomfortable and costly. The study will compare the device's spleen stiffness readings against endoscopy results in 246 patients to see if it can accurately identify who has varices and who is at high risk of bleeding. If successful, this could provide a quick, non-invasive screening tool to help prevent life-threatening bleeding episodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pro9000X, a liver shear wave quantization detector that measures spleen stiffness non-invasively
What this could lead to
If proven accurate, this could offer a safe, painless alternative to endoscopy for spotting dangerous varices, potentially saving lives by enabling earlier detection and treatment.
What could go wrong
The test may not be accurate enough to replace endoscopy in all cases, and its performance could vary across different liver diseases. It is still under evaluation, so its real-world usefulness is not yet confirmed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 246 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with chronic liver disease who met the protocol inclusion and exclusion criteria

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age over 18 years old, male or female; 2. patients with clinically diagnosed chronic liver disease, including hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, fatty liver disease, autoimmune liver disease, and alcoholic liver disease \*; 3. Liver stiffness measurement (LSM) ≥10kPa during screening or within one month before screening \[4\]; 4. able to communicate well with the investigators, understand and comply with the requirements of the study; 5. Informed consent was signed voluntarily. Exclusion Criteria: 1. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 U/L; 2. complicated with jaundice (serum total bilirubin ≥50 μmol/L); 3. complicated with important organ diseases (except liver) or serious systemic diseases (such as malignant tumors and HIV); 4. after liver transplantation or TIPS; 5. after splenectomy, splenic embolization or other portasystemic shunts; 6. patients with moderate-to-large amount of ascites; 7. unstable condition in the acute stage of esophageal variceal bleeding; 8. combined with liver malignant tumors; 9. patients with non-cirrhotic portal hypertension, Budd-Chiari syndrome and other hepatic vascular diseases; Acute or chronic portal vein thrombosis; 10. unhealed wounds or scars in the left abdomen were not suitable for ultrasound examination; 11. pregnant women; 12. Other conditions judged by the investigators as not suitable for participating in the study.

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Conditions

The condition(s) this trial relates to.

esophageal varices

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic liver diseases Diagnostic performance study Esophageal varices Spleen stiffness

How to take part

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  1. The official record

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