Liver BiopsyPhase 4NCT00643656
Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion
A Phase 4 study testing Kalinox 170 bar and Mix of 50% oxygen and 50% nitrogen in people with Liver Biopsy, run by Air Liquide Santé International at 1 site in France.
Trial summary
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Biopsy
- What is being tested?
- Kalinox 170 bar and Mix of 50% oxygen and 50% nitrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 4
- 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
- patient requiring a liver biopsy of focal lesion
- Age upper than 18 years
- OMS : 0 to 3
- patient consent form signed
Who cannot join
- patient unable to use Visual Analog Scale (VAS)
- OMS upper than 3
- coagulation disorder
- contraindication linked to the experimental product
- patient already included in another clinical trial uncompatible with this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.
- Conditions
- Liver Biopsy
- Being tested
- Kalinox 170 bar, Mix of 50% oxygen and 50% nitrogen
- Keywords
- Liver biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kalinox 170 barDrug
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
Mix of 50% oxygen and 50% nitrogenDrug
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Mixture of 50% nitrous oxide and 50% oxygen Receives: Drug: Kalinox 170 bar |
| B | Placebo comparator | Mixture of 50% oxygen and 50% nitrogen Receives: Drug: Mix of 50% oxygen and 50% nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement by using Visual Analog Scale (VAS)
Measured: At the end of the liver biospy
Secondary outcomes (1)
Patient's acceptance and doctor's satisfaction
Measured: At the end of the liver biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver BiopsyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643656
- Sponsor's protocol ID
- EudraCT : 2006-004203-19
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2008
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Meskine N, Vullierme MP, Zappa M, d'Assignies G, Sibert A, Vilgrain V. Evaluation of analgesic effect of equimolar mixture of oxygen and nitrous oxide inhalation during percutaneous biopsy of focal liver lesions: a double-blind randomized study. Acad Radiol. 2011 Jul;18(7):816-21. doi: 10.1016/j.acra.2011.01.025. Epub 2011 Apr 20.
PubMed 21511500
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion
- ClinicalTrials.gov ID
- NCT00643656
- Acronym / sponsor ID
- EudraCT : 2006-004203-19
- Conditions
- Liver Biopsy
- Keywords
- Liver biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Mar 2008 (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.
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Kalinox 170 barMixture of 50% nitrous oxide and 50% oxygen |
| B | Placebo comparator | Drug: Mix of 50% oxygen and 50% nitrogenMixture of 50% oxygen and 50% nitrogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient requiring a liver biopsy of focal lesion
- Age upper than 18 years
- OMS : 0 to 3
- patient consent form signed
Key exclusion criteria (5 listed)
- patient unable to use Visual Analog Scale (VAS)
- OMS upper than 3
- coagulation disorder
- contraindication linked to the experimental product
- patient already included in another clinical trial uncompatible with this trial
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 |
|---|---|---|
| Kalinox 170 barFlow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour | Drug | A |
| Mix of 50% oxygen and 50% nitrogenFlow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour | Drug | B |
Primary outcome
Pain measurement by using Visual Analog Scale (VAS)
Time frame: At the end of the liver biospy
1 secondary outcome
Patient's acceptance and doctor's satisfaction
Time frame: At the end of the liver biopsy
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 13 Mar 2025.
- Results publication: PubMed 21511500Meskine N, Vullierme MP, Zappa M, d'Assignies G, Sibert A, Vilgrain V. Evaluation of analgesic effect of equimolar mixture of oxygen and nitrous oxide inhalation during percutaneous biopsy of focal liver lesions: a double-blind randomized study. Acad Radiol. 2011 Jul;18(7):816-21. doi: 10.1016/j.acra.2011.01.025. Epub 2011 Apr 20.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kalinox 170 bar and Mix of 50% oxygen and 50% nitrogen in people with Liver Biopsy, run by Air Liquide Santé International 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 5 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 13 Mar 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain measurement by using Visual Analog Scale (VAS) (time frame: At the end of the liver biospy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643656, which also lists 1 linked publication.
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 13 Mar 2025.