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

Primary Purpose

Lung Tumor, Bone Tumor, Renal Tumor

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Microwave ablation with Acculis Accu2i pMTA Applicator
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Tumor

Eligibility Criteria

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

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

Sites / Locations

  • CHU Besançon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Renal tumor

Lung tumor

Bone tumor

Arm Description

Microwave ablation of renal tumor

Microwave ablation of lung tumor

Microwave ablation of bone tumor

Outcomes

Primary Outcome Measures

Tumor necrosis rate in post-intervention over one month monitoring period.

Secondary Outcome Measures

Full Information

First Posted
August 1, 2016
Last Updated
August 8, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02862288
Brief Title
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
Acronym
TherMO
Official Title
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Tumor, Bone Tumor, Renal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal tumor
Arm Type
Experimental
Arm Description
Microwave ablation of renal tumor
Arm Title
Lung tumor
Arm Type
Experimental
Arm Description
Microwave ablation of lung tumor
Arm Title
Bone tumor
Arm Type
Experimental
Arm Description
Microwave ablation of bone tumor
Intervention Type
Device
Intervention Name(s)
Microwave ablation with Acculis Accu2i pMTA Applicator
Primary Outcome Measure Information:
Title
Tumor necrosis rate in post-intervention over one month monitoring period.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Aubry, M.D.
Organizational Affiliation
Centre hospitalier régional universitaire de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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