NCT00892255

Brief Summary

The purpose of this protocol is to pathologically evaluate the destruction by microwave ablation of primary and metastatic liver tumors. The primary aim is to measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

April 30, 2009

Last Update Submit

March 30, 2021

Conditions

Hepatocellular CarcinomaLiver Cancer

Keywords

Liver cancerTumors

Outcome Measures

Primary Outcomes (1)

  • Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System

    Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation

    30 Days

Interventions

Microwave AblationDEVICE

Tumor tissue from the liver is inter-operatively treated with the microwave ablation device to measure the destruction of tissue.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for liver resection, either for primary or metastatic disease

You may qualify if:

  • Diagnosis of primary or metastatic liver cancer for which surgery is planned
  • All participants need to be fully able to give informed consent

You may not qualify if:

  • Mental or legal incompetence
  • Impaired decision-making capacity
  • Pregnant women may not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Cancer Prevention & Treatment at St. Joseph Hospital

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hisham El-Bayar, MD

    St. Joseph Hospital of Orange

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 4, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 2, 2021

Record last verified: 2021-03

Locations

US(1)