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

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lung Tumor; Bone Tumor; Renal Tumor

Treatments: Device: Microwave ablation with Acculis Accu2i pMTA Applicator

Study type: Interventional

Funder types: Other

Identifiers

NCT02862288

API/2011/23

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Renal tumor

Experimental group

Description:

Microwave ablation of renal tumor

Treatment:

Device: Microwave ablation with Acculis Accu2i pMTA Applicator

Lung tumor

Experimental group

Description:

Microwave ablation of lung tumor

Treatment:

Device: Microwave ablation with Acculis Accu2i pMTA Applicator

Bone tumor

Experimental group

Description:

Microwave ablation of bone tumor

Treatment:

Device: Microwave ablation with Acculis Accu2i pMTA Applicator