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

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

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:

  1. Biopsy or clinical diagnosis of HCC
  2. Complete clinical information and preoperative CEUS
  3. Curative treatment

Exclusion Criteria:

  1. Palliative care
  2. Intolerance to ablation
  3. 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
Procedure: Microwave Thermal guided by Plan for Microwave Thermal Field system
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
Postoperative MRI is used to determine whether the ablation zone completely covers the tumor and whether the size is appropriate
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

Chinese PLA General Hospital

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

Keywords

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.

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