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

NCT ID: NCT02862288

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Tumor Bone Tumor Renal Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal tumor

Microwave ablation of renal tumor

Group Type EXPERIMENTAL

Microwave ablation with Acculis Accu2i pMTA Applicator

Intervention Type DEVICE

Lung tumor

Microwave ablation of lung tumor

Group Type EXPERIMENTAL

Microwave ablation with Acculis Accu2i pMTA Applicator

Intervention Type DEVICE

Bone tumor

Microwave ablation of bone tumor

Group Type EXPERIMENTAL

Microwave ablation with Acculis Accu2i pMTA Applicator

Intervention Type DEVICE

Interventions

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Microwave ablation with Acculis Accu2i pMTA Applicator

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Aubry, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier régional universitaire de Besançon

Locations

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CHU Besançon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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API/2011/23

Identifier Type: -

Identifier Source: org_study_id

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