Heart DiseasesDISTINCTNCT06392243
IntraCardiac Echocardiography sysTem
A study testing Intracardiac ultrasound imaging system in people with Heart Diseases, run by Sonosemi Medical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Intracardiac ultrasound imaging system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2022to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged ≥18 years and ≤85 years, regardless of gender,
- patients who planned to undergo intracardiac and macrovascular imaging, intracardiac Doppler flow assessment, and intracardiac intervention,
- subjects who could understand the purpose of the trial, were willing to cooperate with interventional treatment and follow-up, participated in the trial voluntarily and signed a written informed consent.
Who cannot join
- known complication of sepsis, thrombosis or severe peripheral vascular disease;
- angina class IV CCS or NYHA Class IV cardiac function,
- severe Coagulopathy unable to perform vascular puncture,
- known to be severely allergic to the materials used in the study;
- pregnant or lactating women, or those who had planned to become pregnant during the trial;
- those who were enrolled in any other drug or medical device clinical trial and had not yet left the group;
- other conditions that the investigator judged unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicenter, ranDomized Controlled, Non-Inferior Clinical Trial to Evaluate the SafeTy and effIcacy of a Novel intraCardiac Echocardiography sysTem（DISTINCT Trial）
To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co., Ltd.
Read the detailed description
A prospective, multicenter, randomized controlled, non-inferiority clinical trial was designed. In the experimental group, intracardiac and large blood vessel imaging, intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of Sonosemi Medical Co., Ltd. The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention. After meeting the entry criteria, they will be randomized by an electronic randomization system, and the researchers will conduct a clinical trial based on the results of the randomization, intracardiac and large vessel imaging, intracardiac Doppler flow assessment, and guidance of intracardiac intervention were performed in both groups
- Conditions
- Heart Diseases
- Being tested
- Intracardiac ultrasound imaging system
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac ultrasound imaging systemDevice
The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In the experimental group, intracardiac and large blood vessel imaging, intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of Sonosemi Medical Co., Ltd. Receives: Device: Intracardiac ultrasound imaging system |
| Control Group | Active comparator | The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention Receives: Device: Intracardiac ultrasound imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent rate of image
In intracardiac and large-vessel endocardial imaging of the heart, the researchers determined the ratio of"Excellent" to"Good" ultrasound image quality
Measured: 0 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start22 Oct 2022
- Primary completion23 Oct 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonosemi Medical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Ben, Principal investigator, Shanghai Chest HospitalChu Huimin, Principal investigator, Ningbo No. 1 HospitalLi Haiying, Principal investigator, The University of Hong Kong-Shenzhen HospitalMa Wei, Principal investigator, Peking University First HospitalNing Zhongping, Principal investigator, Zhoupu Hospital, Pudong New Area, Shanghai, ChinaZhang Xiwen, Principal investigator, Huai'an First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392243
- Sponsor's protocol ID
- UC002
- Acronym
- DISTINCT
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, ranDomized Controlled, Non-Inferior Clinical Trial to Evaluate the SafeTy and effIcacy of a Novel intraCardiac Echocardiography sysTem（DISTINCT Trial）
- ClinicalTrials.gov ID
- NCT06392243
- Acronym / sponsor ID
- DISTINCT / UC002
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Sonosemi Medical Co., Ltd.University, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co., Ltd.
Detailed description
A prospective, multicenter, randomized controlled, non-inferiority clinical trial was designed. In the experimental group, intracardiac and large blood vessel imaging, intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of Sonosemi Medical Co., Ltd. The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention. After meeting the entry criteria, they will be randomized by an electronic randomization system, and the researchers will conduct a clinical trial based on the results of the randomization, intracardiac and large vessel imaging, intracardiac Doppler flow assessment, and guidance of intracardiac intervention were performed in both groups
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Intracardiac ultrasound imaging systemIn the experimental group, intracardiac and large blood vessel imaging, intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of Sonosemi Medical Co., Ltd. |
| Control Group | Active comparator | Device: Intracardiac ultrasound imaging systemThe control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged ≥18 years and ≤85 years, regardless of gender,
- patients who planned to undergo intracardiac and macrovascular imaging, intracardiac Doppler flow assessment, and intracardiac intervention,
- subjects who could understand the purpose of the trial, were willing to cooperate with interventional treatment and follow-up, participated in the trial voluntarily and signed a written informed consent.
Key exclusion criteria (7 listed)
- known complication of sepsis, thrombosis or severe peripheral vascular disease;
- angina class IV CCS or NYHA Class IV cardiac function,
- severe Coagulopathy unable to perform vascular puncture,
- known to be severely allergic to the materials used in the study;
- pregnant or lactating women, or those who had planned to become pregnant during the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracardiac ultrasound imaging systemThe control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention | Device | Control Group, Experimental group |
Primary outcome
Excellent rate of image
Time frame: 0 days after the operation
In intracardiac and large-vessel endocardial imaging of the heart, the researchers determined the ratio of"Excellent" to"Good" ultrasound image quality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Ben principal investigator
Shanghai Chest Hospital
Chu Huimin principal investigator
Ningbo No. 1 Hospital
Li Haiying principal investigator
The University of Hong Kong-Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracardiac ultrasound imaging system in people with Heart Diseases, run by Sonosemi Medical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent rate of image (time frame: 0 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.