To Improve the Clinical Outcome of Ultrasound-guided Radi... | NCT05818176

Studies
To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.

NCT05818176

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Apr 18, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Radiofrequency Ablation

Interventions

NAVIRFA® Navigation System
ultrasound

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2023

Last Update Posted Date

Apr 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ultrasonic-guided radiofrequency ablation is the most common minimally invasive treatment for liver cancer. This study will use my country's self-developed intelligent ultrasonic navigation tool (NAVIRFA® Navigation System) to assist in the puncture of the needle during ablation, to observe the operation time, Whether the needle accuracy, ablation effect and complications are different from the traditional free-hand ultrasonic guidance technology.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAVIRFA® Navigation System	Experimental		Device: NAVIRFA® Navigation System
ultrasound-guided	Active Comparator		Device: ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NAVIRFA® Navigation System	Device	radiofrequency ablation by NAVIRFA® Navigation System.	NAVIRFA® Navigation System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
required scan time	the time required until start of the ablation (measured from the time of the first US scan to the start of the ablation).	Before ablation treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with malignant liver tumors less than three centimeters in size who are expected to suffer radiofrequency tumor ablation in the hospital.
At least 20 years old.

Exclusion Criteria:

Patients with abnormal coagulation function and low platelets are not suitable for ablation therapy after evaluation by the trial host.
Those who are unable to accept computerized tomography and MRI examinations, such as poor renal function or contrast agent allergy, are not suitable for examination after the evaluation of the test host.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kai-Wen Huang, MD, PhD	Contact	+886-23123456	265915	fangyu0429@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei, Taiwan			Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided