Bone CystsNCT05880628
Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts
An observational study of Bone Cysts, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Cysts
- What is being tested?
- datas of medical record.
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2022to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel will be included.
Who may be able to join
- Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel
Who cannot join
- Refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Sylvain Grange, MD
Valentin Gineys, resident
About this study
There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.
Read the detailed description
The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.
- Conditions
- Bone Cysts
- Being tested
- datas of medical record.
- Keywords
- Bone Cysts, Aneurysmal Bone Cysts, simple Bone Cysts, Discogel, Effectiveness, Safety
- Medical subject headings
- Bone Cysts, Bone Cysts, Aneurysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
datas of medical record.Other
Analysis datas of medical record:
- Feasibility of the technique
- Safety of the technique
- Efficacity (sclerose of the lesion)
| Study group | Role | What they receive |
|---|---|---|
| Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® | Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® will be included.
Analysis datas of medical record. Receives: Other: datas of medical record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the technique
Collect from medical records the number of procedures that were completed and performed as theoretically intended.
Measured: Year: 2
Secondary outcomes (2)
Safety of the technique by number of adverse event
collect in the medical record
Measured: Year: 2
Number of discogel® injections by sclerose of the lesion
Efficacity of the technique
Measured: Year: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start14 Apr 2022
- 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 CystsStudies 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
- 30 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
- NCT05880628
- Sponsor's protocol ID
- IRBN552022/CHUSTE
- Status last verified
- Mar 2024
- First submitted
- 19 May 2023
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts
- ClinicalTrials.gov ID
- NCT05880628
- Acronym / sponsor ID
- IRBN552022/CHUSTE
- Conditions
- Bone Cysts
- Keywords
- Bone Cysts, Aneurysmal Bone Cysts, simple Bone Cysts, Discogel, Effectiveness, Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 May 2023 (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.
There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.
Detailed description
The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® | – | Other: datas of medical record.Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® will be included. Analysis datas of medical record. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel will be included.
Key inclusion criteria (1 listed)
- Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel
Key exclusion criteria (1 listed)
- Refusal
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 |
|---|---|---|
| datas of medical record.Analysis datas of medical record: * Feasibility of the technique * Safety of the technique * Efficacity (sclerose of the lesion) | Other | Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® |
Primary outcome
Feasibility of the technique
Time frame: Year: 2
Collect from medical records the number of procedures that were completed and performed as theoretically intended.
2 secondary outcomes
Safety of the technique by number of adverse event
Time frame: Year: 2
Number of discogel® injections by sclerose of the lesion
Time frame: Year: 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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 Cysts, 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 12 Mar 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-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the technique (time frame: Year: 2). 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 12 Mar 2024.