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

Phase 1

Completed

• Conditions: Bone Tumor; Renal Tumor; Lung Tumor
• Interventions: Device: Microwave ablation with Acculis Accu2i pMTA Applicator

• Registration Number: NCT02862288
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2015-02
• Study Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Study First Posted: 2016-08-11
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung tumor	Microwave ablation with Acculis Accu2i pMTA Applicator	Microwave ablation of lung tumor
Renal tumor	Microwave ablation with Acculis Accu2i pMTA Applicator	Microwave ablation of renal tumor
Bone tumor	Microwave ablation with Acculis Accu2i pMTA Applicator	Microwave ablation of bone tumor

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU Besançon; 🇫🇷 Besançon, France