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

Bone Tumor Clinical Trial

— TherMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862288
• Other study ID #: API/2011/23
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 1, 2016
• Last updated: August 8, 2016
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumor
• Kidney Neoplasms
• Lung Tumor
• Renal Tumor

Intervention

Device:
• Microwave ablation with Acculis Accu2i pMTA Applicator

Locations

Country	Name	City	State
France	CHU Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor necrosis rate in post-intervention over one month monitoring period.		one month	Yes