- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05270642
Plan for Microwave Thermal Field
March 7, 2022 updated by: Ping Liang, Chinese PLA General Hospital
Research on Intelligent System of Plan for Microwave Thermal Field for Hepatocellular Carcinoma
Develop an intelligent system based on contrast-enhanced ultrasound and clinical information to help doctors automatically obtain ablation parameters (ablation needle number, ablation needle type, ablation time,ablation power) when preparing to use microwave ablation to treat hepatocellular carcinoma
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100853
- Chinese PLA General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Biopsy or clinical diagnosis of HCC
- Complete clinical information and preoperative CEUS
- Curative treatment
Exclusion Criteria:
- Palliative care
- Intolerance to ablation
- Severe coagulation disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HCC patients guided by Plan for Microwave Thermal Field
The plan for HCC patients undergoing microwave ablation would be refer to Plan for Microwave Thermal Field system
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When HCC patients undergo microwave ablation, the doctor will refer to the ablation plan provided by the system.If the plan is consistent with what the doctor thinks, follow the plan provided by the system.
If the protocol is not consistent with what the doctor thinks, the doctor will revise the protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MRI within 3 days after ablation
Time Frame: MRI within 3 days after ablation
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Postoperative MRI is used to determine whether the ablation zone completely covers the tumor and whether the size is appropriate
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MRI within 3 days after ablation
|
|
local tumor progression
Time Frame: 6 months
|
Follow up to observe whether local tumor progression occurs within 6 months after ablation
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
February 27, 2022
First Submitted That Met QC Criteria
March 7, 2022
First Posted (Actual)
March 8, 2022
Study Record Updates
Last Update Posted (Actual)
March 8, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2021-439-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.