NCT00869843

Brief Summary

  • To determine the depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball.
  • To determine the efficacy of the technique on surface liver tumors using saline linked RF surface ablati
  • To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow occlusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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, 2002

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

5 years

First QC Date

March 25, 2009

Last Update Submit

April 22, 2013

Conditions

Malignant Liver TumorsLiver Metastases From Colorectal Cancer

Keywords

Metastatic colorectal cancer

Outcome Measures

Primary Outcomes (2)

  • Depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball

    On day of surgery

    Day 1

  • Efficacy of the technique on surface liver tumors using saline lined RF Surface ablation.

    On day of surgery

    Day 1

Secondary Outcomes (1)

  • Determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion and a 2 cm depth with inflow occlusion.

    Day 1

Study Arms (1)

Single group

OTHER
Procedure: RF Ablation

Interventions

RF AblationPROCEDURE
Single group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility for Stage I (Normal Liver Tissue) * Resectable liver metastases from malignant liver tumors, primary or secondary * Patient has been scheduled for liver resection and is in generally good medical condition * No evidence of extra-hepatic disease * Patient does not have a pacemaker * Age \>= 18 * Able to provide informed consent Eligibility for Stage II (Patients with liver metastases from colorectal cancer) * Resectable liver metastases from colorectal cancer * Patient has been scheduled for liver resection is in generally good medical condition * No evidence of extra-hepatic disease. * Patient does not have a pacemaker * Age \>= 18 * Able to provide informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Gnerlich JL, Ritter JH, Linehan DC, Hawkins WG, Strasberg SM. Saline-linked surface radiofrequency ablation: a safe and effective method of surface ablation of hepatic metastatic colorectal cancer. Ann Surg. 2009 Jul;250(1):96-102. doi: 10.1097/SLA.0b013e3181ae91af.

    PMID: 19561459DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Steven Strasberg, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

October 1, 2002

Primary Completion

October 1, 2007

Study Completion

March 1, 2009

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

US(1)