Lung TumorPhase 1/2TherMONCT02862288
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
A Phase 1/2 study testing Microwave ablation with Acculis Accu2i pMTA Applicator in people with Lung Tumor and Bone Tumor, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Tumor, Bone Tumor, Renal Tumor
- What is being tested?
- Microwave ablation with Acculis Accu2i pMTA Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Tumor, Bone Tumor, Renal Tumor
- Being tested
- Microwave ablation with Acculis Accu2i pMTA Applicator
- Medical subject headings
- Lung Neoplasms, Bone Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablation with Acculis Accu2i pMTA ApplicatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Renal tumor | Experimental | Microwave ablation of renal tumor Receives: Device: Microwave ablation with Acculis Accu2i pMTA Applicator |
| Lung tumor | Experimental | Microwave ablation of lung tumor Receives: Device: Microwave ablation with Acculis Accu2i pMTA Applicator |
| Bone tumor | Experimental | Microwave ablation of bone tumor Receives: Device: Microwave ablation with Acculis Accu2i pMTA Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor necrosis rate in post-intervention over one month monitoring period.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TumorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Aubry, M.D., Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862288
- Sponsor's protocol ID
- API/2011/23
- Acronym
- TherMO
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
- ClinicalTrials.gov ID
- NCT02862288
- Acronym / sponsor ID
- TherMO / API/2011/23
- Conditions
- Lung Tumor, Bone Tumor, Renal Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Renal tumor | Experimental | Device: Microwave ablation with Acculis Accu2i pMTA ApplicatorMicrowave ablation of renal tumor |
| Lung tumor | Experimental | Device: Microwave ablation with Acculis Accu2i pMTA ApplicatorMicrowave ablation of lung tumor |
| Bone tumor | Experimental | Device: Microwave ablation with Acculis Accu2i pMTA ApplicatorMicrowave ablation of bone tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablation with Acculis Accu2i pMTA Applicator | Device | Bone tumor, Lung tumor, Renal tumor |
Primary outcome
Tumor necrosis rate in post-intervention over one month monitoring period.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Aubry, M.D. principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Microwave ablation with Acculis Accu2i pMTA Applicator in people with Lung Tumor and Bone Tumor, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor necrosis rate in post-intervention over one month monitoring period. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.