Back to resultsPlan for Microwave Thermal Field
Primary Purpose
Hepatocellular Carcinoma, Ablation
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microwave Thermal guided by Plan for Microwave Thermal Field system
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular Carcinoma, microwave ablation
Eligibility Criteria
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
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCC patients guided by Plan for Microwave Thermal Field
Arm Description
The plan for HCC patients undergoing microwave ablation would be refer to Plan for Microwave Thermal Field system
Outcomes
Primary Outcome Measures
MRI within 3 days after ablation
Postoperative MRI is used to determine whether the ablation zone completely covers the tumor and whether the size is appropriate
local tumor progression
Follow up to observe whether local tumor progression occurs within 6 months after ablation
Secondary Outcome Measures
Full Information
NCT ID
NCT05270642
First Posted
February 27, 2022
Last Updated
March 7, 2022
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05270642
Brief Title
Plan for Microwave Thermal Field
Official Title
Research on Intelligent System of Plan for Microwave Thermal Field for Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Ablation
Keywords
hepatocellular Carcinoma, microwave ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCC patients guided by Plan for Microwave Thermal Field
Arm Type
Experimental
Arm Description
The plan for HCC patients undergoing microwave ablation would be refer to Plan for Microwave Thermal Field system
Intervention Type
Procedure
Intervention Name(s)
Microwave Thermal guided by Plan for Microwave Thermal Field system
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI within 3 days after ablation
Description
Postoperative MRI is used to determine whether the ablation zone completely covers the tumor and whether the size is appropriate
Time Frame
MRI within 3 days after ablation
Title
local tumor progression
Description
Follow up to observe whether local tumor progression occurs within 6 months after ablation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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