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Trial record 32 of 4293 for:    bone tumors AND NOT metastatic

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

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ClinicalTrials.gov Identifier: NCT02862288
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Tumor Bone Tumor Renal Tumor Device: Microwave ablation with Acculis Accu2i pMTA Applicator Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
Study Start Date : September 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Tumor necrosis rate in post-intervention over one month monitoring period. [ Time Frame: one month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862288


Locations
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France
CHU Besançon
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Sébastien Aubry, M.D. Centre Hospitalier régional Universitaire de Besançon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02862288     History of Changes
Other Study ID Numbers: API/2011/23
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases