Percutaneous Tumor AblationPhase 3NCT02813005
High Frequency Jet Ventilation for Percutaneous Interventional Radiology
A Phase 3 study testing Jet ventilation group and Standard ventilation group in people with Percutaneous Tumor Ablation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Tumor Ablation
- What is being tested?
- Jet ventilation group and Standard ventilation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Aug 2018
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- use of percutaneous ablation tumor techniques (<3cm) for inferior lung, superior kidney, superior liver or adrenal gland lesion
Who cannot join
- Severe chronic obstructive pulmonary disease
- Recent pneumothorax (one month)
- Recent thoracic surgery (one month)
- Body Mass Index > 40
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Starsbourg
Strasbourg, 67091
About this study
Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.
The investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.
- Conditions
- Percutaneous Tumor Ablation
- Being tested
- Jet ventilation group, Standard ventilation group
- Keywords
- High frequency jet ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jet ventilation groupProcedure or surgery
Also called Frequence: 120-200/min; Pressure: 1-2 bars; Inspiratory fraction of Oxgen: 50%; Expiratory pressure: 5-10 cmH2O
MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)
Standard ventilation groupProcedure or surgery
Also called apnea made by the anesthesiologist with Primus DRAGER Medical
apnea made by the anesthesiologist to the request of the radiologist
| Study group | Role | What they receive |
|---|---|---|
| Jet ventilation/ group A | Experimental | Frequency : 120-200/min Pressure : 1-2 bars Inspiratory fraction of oxygen : 100% and 50% if Expiratory pressure : 5 -10 cmH2O Receives: Procedure: Jet ventilation group |
| Standard ventilation/ group B | Sham comparator | Apnea made by the anesthesiologist to the request of the radiologist. Receives: Procedure: Standard ventilation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hit the target
Estimated the time for a puncture needle under High Frequency Jet Ventilation compared to the conventional mode of mechanical ventilation
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Tumor AblationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra PETIOT, MD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813005
- Sponsor's protocol ID
- 6370
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Jet Ventilation for Percutaneous Interventional Radiology
- ClinicalTrials.gov ID
- NCT02813005
- Acronym / sponsor ID
- 6370
- Conditions
- Percutaneous Tumor Ablation
- Keywords
- High frequency jet ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 24 Jun 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.
Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.
The investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jet ventilation/ group A | Experimental | Procedure: Jet ventilation groupFrequency : 120-200/min Pressure : 1-2 bars Inspiratory fraction of oxygen : 100% and 50% if Expiratory pressure : 5 -10 cmH2O |
| Standard ventilation/ group B | Sham comparator | Procedure: Standard ventilation groupApnea made by the anesthesiologist to the request of the radiologist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- use of percutaneous ablation tumor techniques (<3cm) for inferior lung, superior kidney, superior liver or adrenal gland lesion
Key exclusion criteria (4 listed)
- Severe chronic obstructive pulmonary disease
- Recent pneumothorax (one month)
- Recent thoracic surgery (one month)
- Body Mass Index > 40
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 |
|---|---|---|
| Jet ventilation groupAlso: Frequence: 120-200/min; Pressure: 1-2 bars; Inspiratory fraction of Oxgen: 50%; Expiratory pressure: 5-10 cmH2OMONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC) | Procedure or surgery | Jet ventilation/ group A |
| Standard ventilation groupAlso: apnea made by the anesthesiologist with Primus DRAGER Medicalapnea made by the anesthesiologist to the request of the radiologist | Procedure or surgery | Standard ventilation/ group B |
Primary outcome
Time to hit the target
Time frame: during the procedure
Estimated the time for a puncture needle under High Frequency Jet Ventilation compared to the conventional mode of mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
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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.
Sandra PETIOT, MD principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jet ventilation group and Standard ventilation group in people with Percutaneous Tumor Ablation, run by University Hospital, Strasbourg, France 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Feb 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra PETIOT, MD (+33 369550443, Sandra.Petiot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hit the target (time frame: during the procedure). 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 20 Feb 2017.