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CompletedNCT02862288TherMOUpdated Aug 11, 2016

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

A Phase 1/2 interventional study of Microwave ablation with Acculis Accu2i pMTA Applicator in Lung Tumor, Bone Tumor and Renal Tumor, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-11.

Sponsored by Centre Hospitalier Universitaire de Besancon · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Tumor
  • Bone Tumor
  • Renal Tumor
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Renal tumor

    Microwave ablation of renal tumor

    Device: Microwave ablation with Acculis Accu2i pMTA Applicator

  • Experimental
    Lung tumor

    Microwave ablation of lung tumor

    Device: Microwave ablation with Acculis Accu2i pMTA Applicator

  • Experimental
    Bone tumor

    Microwave ablation of bone tumor

    Device: Microwave ablation with Acculis Accu2i pMTA Applicator

Interventions

  • DeviceMicrowave ablation with Acculis Accu2i pMTA Applicator
06

What researchers measure

Primary outcomes

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

    Time frame: one month

07

Study locations

1 site
  • CHU Besançon
    Besançon, 25000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02862288
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Sep 2012
Primary completion
Feb 2015
Completion
Dec 2015
Last update
Aug 11, 2016

Study contacts

Sébastien Aubry, M.D.
principal investigator · Centre hospitalier régional universitaire de Besançon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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