Bone AngiomaNCT06607731
Percutaneous Gelled Alcohol Sclerotherapy for Aggressive Angiomas: Evaluation of Feasibility, Safety, and Efficacy
An observational study of Bone Angioma, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The investigators aimed to evaluate efficacy and safety of a non-surgical protocol treatment combining transarterial embolization and percutaneous radiopaque gelled ethanol (RGE) sclerotherapy in a first procedure, then followed by vertebroplasty in a second procedure, to treat aggressive vertebral hemangioma patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Angioma
- What is being tested?
- Collecting data from medical records
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2024to Dec 2024
- Phase
- Observational
- 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
Study population: All patients who underwent percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Étienne University Hospital will be included.
Who may be able to join
- Every patients treated by gelled alcohol sclerotherapy for aggressive angiomas, in the University Hospital of Saint-Etienne.
Who cannot join
- Patients no treated by gelled alcohol sclerotherapy.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Sylvain Grange, MD, (0)477829066 ext. +33, grangesylvain@hotmail.fr
Sylvain Grange, MD
About this study
The investigators aimed to evaluate efficacy and safety of a non-surgical protocol treatment combining transarterial embolization and percutaneous radiopaque gelled ethanol (RGE) sclerotherapy in a first procedure, then followed by vertebroplasty in a second procedure, to treat aggressive vertebral hemangioma patients in tertiary hospital. Exclusion criteria were age <18-years old and any association with neurological deficit.
- Conditions
- Bone Angioma
- Being tested
- Collecting data from medical records
- Keywords
- percutaneous sclerosis, ethanol gel, aggressive bone angioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting data from medical recordsOther
Data collected: clinical data (particularly pain), biological data, imaging.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients who have undergone percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Etienne University Hospital. Receives: Other: Collecting data from medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications identified in data collection
Number of complications identified in data collection
Measured: Day 1
Secondary outcomes (1)
Number of lesion identified in data collection
Number of lesion identified in data collection
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start25 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AngiomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain GRANGE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607731
- Sponsor's protocol ID
- IRBN312024/CHUSTE
- Status last verified
- Oct 2024
- First submitted
- 26 Jul 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Gelled Alcohol Sclerotherapy for Aggressive Angiomas: Evaluation of Feasibility, Safety, and Efficacy
- ClinicalTrials.gov ID
- NCT06607731
- Acronym / sponsor ID
- IRBN312024/CHUSTE
- Conditions
- Bone Angioma
- Keywords
- percutaneous sclerosis, ethanol gel, aggressive bone angioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Sep 2024 (actual)
- 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 investigators aimed to evaluate efficacy and safety of a non-surgical protocol treatment combining transarterial embolization and percutaneous radiopaque gelled ethanol (RGE) sclerotherapy in a first procedure, then followed by vertebroplasty in a second procedure, to treat aggressive vertebral hemangioma patients in tertiary hospital. Exclusion criteria were age <18-years old and any association with neurological deficit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: Collecting data from medical recordsPatients who have undergone percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Etienne University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Étienne University Hospital will be included.
Key inclusion criteria (1 listed)
- Every patients treated by gelled alcohol sclerotherapy for aggressive angiomas, in the University Hospital of Saint-Etienne.
Key exclusion criteria (1 listed)
- Patients no treated by gelled alcohol sclerotherapy.
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 |
|---|---|---|
| Collecting data from medical recordsData collected: clinical data (particularly pain), biological data, imaging. | Other | Study population |
Primary outcome
Number of complications identified in data collection
Time frame: Day 1
Number of complications identified in data collection
1 secondary outcome
Number of lesion identified in data collection
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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.
Sylvain GRANGE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Angioma, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 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 8 Oct 2024. 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.
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 Sylvain GRANGE, MD ((0)477829066 ext. +33, sylvain.grange@chu-st-étienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complications identified in data collection (time frame: Day 1). 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 8 Oct 2024.