Skip to content

A prospective, multi-center, paired-design clinical trial evaluating the safety and efficacy of an ultrasound contrast injection device for detecting right-to-left shunts.

A prospective, multi-center, paired-design clinical trial evaluating the safety and efficacy of an ultrasound contrast injection device for detecting right-to-left shunts.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123225
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Used to aid ultrasound in the screening of right-to-left blood shunting (RLS) within the heart.

Interventions

Test group:Ultrasound contrast injection device.
Control group:Artificial foaming test inspection.

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 16 to 65 years old, no gender restrictions. 2. Clinical suspicion of right-to-left shunt: presence of patent foramen ovale (PFO) or PFO-related stroke, transient ischemic attack (TIA), or premonitory symptoms of migraine. 3. Ability to perform a right-sided cardiac echocardiogram (cTTE) or transcranial Doppler ultrasound-angiography (cTCD) assessment for evaluation of right-to-left shunt. 4. Ability to perform the Valsalva maneuver. I understand the purpose of the trial, voluntarily agree to participate in it, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals with severe multi-organ failure. 2. Suffering from intellectual disabilities or severe hearing impairments. 3. Individuals who, for various reasons, are unable to receive intravenous administration of physiologic saline. 4. Those who are unable to administer the contrast agent due to issues related to puncturing blood vessels. 5. Female participants during pregnancy and breastfeeding. The researchers determined that there were other circumstances under which an individual would not be suitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Consistency rate of right-to-left shunt detection.;Right-to-left shunt grading.;

Secondary

MeasureTime frame
Success rate of the procedure.;Diagnostic success rate.;

Countries

China

Contacts

Public ContactJie Ma

The First Hospital of Hebei Medical University

believe_ma.student@sina.com+86 311 8591 7000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026