NCT05270642

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

February 27, 2022

Last Update Submit

March 7, 2022

Conditions

Keywords

hepatocellular Carcinomamicrowave ablation

Outcome Measures

Primary Outcomes (2)

  • 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

    Follow up to observe whether local tumor progression occurs within 6 months after ablation

    6 months

Study Arms (1)

HCC patients guided by Plan for Microwave Thermal Field

EXPERIMENTAL

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

Interventions

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.

HCC patients guided by Plan for Microwave Thermal Field

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy or clinical diagnosis of HCC
  • Complete clinical information and preoperative CEUS
  • Curative treatment

You may not qualify if:

  • Palliative care
  • Intolerance to ablation
  • Severe coagulation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 27, 2022

First Posted

March 8, 2022

Study Start

October 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations