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Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

Primary Purpose

Carcinoma, Hepatocellular, Hepatocellular Carcinoma, Hepatocellular Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Microwave ablation
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular Carcinoma; liver cancer; cancer; liver

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, Barcelona Clinic Liver Cancer (BCLC) Stage A based on imaging and biopsy confirmation
  2. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only;
  3. Scheduled for microwave ablation of the liver;
  4. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
  5. Functional hepatic reserve based on the Child-Pugh score (Class A or B);
  6. American Society of Anesthesiologists (ASA) score < 3;
  7. Given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the Sponsor, and willing to comply with study-related evaluation and treatment schedule;
  8. At least 19 years of age

Exclusion Criteria:

  1. Active bacterial infection or fungal infection;
  2. Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure;
  3. Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure;
  4. Subject with implantable pacemakers or other electronic implants;
  5. Planned/ scheduled liver surgery.
  6. Subject with a platelet count of less than 20,000/mm3;
  7. Subject with an INR greater than 1.5;
  8. Subject with renal failure on renal dialysis;
  9. Scheduled concurrent procedure other than microwave ablation in the liver;
  10. Pregnant or lactating;
  11. Physical or psychological condition which would impair study participation;
  12. Participation in any other clinical study concurrently or within the last 3 months;
  13. The subject is judged unsuitable for study participation by the Investigator for any other reason;
  14. Unable or unwilling to attend follow-up visits and examinations.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave Ablation

Arm Description

All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories

Outcomes

Primary Outcome Measures

Number of Patients Whose Ablation Resulted in Technical Success
complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced MRI and CT scans

Secondary Outcome Measures

Number of Patients Whose Ablation Resulted in Technique Efficacy
complete tumor ablation with adequate or insufficient ablation margin based on contrast-enhanced MRI and CT scans; scans may be done up to 14 days prior to the 1 month visit

Full Information

First Posted
February 8, 2018
Last Updated
June 28, 2023
Sponsor
Ethicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03586050
Brief Title
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Official Title
A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.
Detailed Description
This prospective, single-arm single center study will provide clinical data for the Neuwave Medical Microwave Ablation System and accessories. Individuals who undergo microwave ablation of liver tumors who meet study entry criteria, will be enrolled. The enrollment for the study will continue until 30 eligible subjects complete the 3-month visit after ablation for the primary effectiveness and safety analysis. The subjects will be followed for approximately up to 36 months after the ablation procedure for safety, oncologic and ablation outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Hepatocellular Carcinoma, Hepatocellular Cancer, Cancer, Hepatocellular
Keywords
Hepatocellular Carcinoma; liver cancer; cancer; liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microwave Ablation
Arm Type
Experimental
Arm Description
All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories
Intervention Type
Device
Intervention Name(s)
Microwave ablation
Intervention Description
All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories
Primary Outcome Measure Information:
Title
Number of Patients Whose Ablation Resulted in Technical Success
Description
complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced MRI and CT scans
Time Frame
immediately following (or up to 4 days after) the ablation procedure (Day 0)
Secondary Outcome Measure Information:
Title
Number of Patients Whose Ablation Resulted in Technique Efficacy
Description
complete tumor ablation with adequate or insufficient ablation margin based on contrast-enhanced MRI and CT scans; scans may be done up to 14 days prior to the 1 month visit
Time Frame
1 month after the ablation procedure (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, Barcelona Clinic Liver Cancer (BCLC) Stage A based on imaging and biopsy confirmation Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only; Scheduled for microwave ablation of the liver; Performance status 0-1 (Eastern Cooperative Oncology Group classification); Functional hepatic reserve based on the Child-Pugh score (Class A or B); American Society of Anesthesiologists (ASA) score < 3; Given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the Sponsor, and willing to comply with study-related evaluation and treatment schedule; At least 19 years of age Exclusion Criteria: Active bacterial infection or fungal infection; Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure; Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure; Subject with implantable pacemakers or other electronic implants; Planned/ scheduled liver surgery. Subject with a platelet count of less than 20,000/mm3; Subject with an INR greater than 1.5; Subject with renal failure on renal dialysis; Scheduled concurrent procedure other than microwave ablation in the liver; Pregnant or lactating; Physical or psychological condition which would impair study participation; Participation in any other clinical study concurrently or within the last 3 months; The subject is judged unsuitable for study participation by the Investigator for any other reason; Unable or unwilling to attend follow-up visits and examinations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunchul Rhim, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

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