Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia. (TherMO)

August 8, 2016 updated by: Centre Hospitalier Universitaire de Besancon
The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women > 18 years old
  • Thermoablation indication of renal neoplasia, bone or lung decided during a multidisciplinary consultation meeting - Generally speaking, the indications are: (i) inoperable primary malignant tumor or secondary malignant tumor, (ii) resectable primary malignant renal and lung tumor with medical contraindication to surgery or general anesthesia
  • Signature of informed consent for participation
  • Affiliation to a social security scheme or French beneficiary of such a regime.

Exclusion Criteria:

  • Contraindication to percutaneous thermoablation
  • Renal or lung tumor up to 4 cm
  • Women of childbearing age, premenopausal, non-sterilized surgically, and unwilling to use effective contraception
  • Legal incapacity or legal capacity limited
  • Person unlikely to cooperate in the study and / or low degree of cooperation expected by the investigator
  • Person without health insurance
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal tumor
Microwave ablation of renal tumor
Device: Microwave ablation with Acculis Accu2i pMTA Applicator
Experimental: Lung tumor
Microwave ablation of lung tumor
Device: Microwave ablation with Acculis Accu2i pMTA Applicator
Experimental: Bone tumor
Microwave ablation of bone tumor
Device: Microwave ablation with Acculis Accu2i pMTA Applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor necrosis rate in post-intervention over one month monitoring period.
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Sébastien Aubry, M.D., Centre Hospitalier Régional Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2011/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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