Bone CystsKOA-RINCT05075148
Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment
An observational study of Bone Cysts, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization) Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Bone Cysts
- What is being tested?
- radiology
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Mar 2022
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Aneurysmal bone cyst
Who may be able to join
- Male of female
- Aging from 0 to 30 years
- With typical aneurysmal bone cyst at initial imaging
- At least one interventional radiology procedure performed
Who cannot join
- No initial surgery
- Patient refuses to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome
This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)
- Conditions
- Bone Cysts
- Being tested
- radiology
- Keywords
- Radiology, Interventional, Epidemiology, Vascualr embolisation, Percutaneous alcoholization, Aneurysmal bone cyst
- 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.
radiologyOther
Interventional radiology for aneurysmal bone cyst ( percutaneous alcoholization, vascualr embolisation)
| Study group | Role | What they receive |
|---|---|---|
| Aneurysmal bone cyst | Patient aging from 0 to 30 years with diagnosis of aneurysmal bone cyst treated by percutaneous alcolisation or endovascular embolization. Receives: Other: radiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of size lesion after treatement
Percentage of peripheral reossification after treatment :
- 0%: no reossification
- < 25%: low reossification
- Between 25% -50%: Partial reossification
- Between 50-75%: significant reossification
- > 75%: very significant reossification
- 100%: complete reossifcation
Measured: day 1
Secondary outcomes (3)
Number of pain
Pain measured with Pain scale ( 0 = no pain , 10 = maximum pain)
Measured: day 1
number of deficience
Number of patients needs second treatment 3- Fracture ? (yes or no)
Measured: day 1
number of complication
Fracture ? (yes or no)
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 posted12 Oct 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Mar 2022 (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 University Hospital, MontpellierThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine CYTEVAL, MD.PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075148
- Sponsor's protocol ID
- RECHMPL21_0029
- Acronym
- KOA-RI
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome
- ClinicalTrials.gov ID
- NCT05075148
- Acronym / sponsor ID
- KOA-RI / RECHMPL21_0029
- Conditions
- Bone Cysts
- Keywords
- Radiology, Interventional, Epidemiology, Vascualr embolisation, Percutaneous alcoholization, Aneurysmal bone cyst
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 12 Oct 2021 (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.
This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aneurysmal bone cyst | – | Other: radiologyPatient aging from 0 to 30 years with diagnosis of aneurysmal bone cyst treated by percutaneous alcolisation or endovascular embolization. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Aneurysmal bone cyst
Key inclusion criteria (4 listed)
- Male of female
- Aging from 0 to 30 years
- With typical aneurysmal bone cyst at initial imaging
- At least one interventional radiology procedure performed
Key exclusion criteria (2 listed)
- No initial surgery
- Patient refuses to participate
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 |
|---|---|---|
| radiologyInterventional radiology for aneurysmal bone cyst ( percutaneous alcoholization, vascualr embolisation) | Other | Aneurysmal bone cyst |
Primary outcome
Difference of size lesion after treatement
Time frame: day 1
Percentage of peripheral reossification after treatment : * 0%: no reossification * < 25%: low reossification * Between 25% -50%: Partial reossification * Between 50-75%: significant reossification * > 75%: very significant reossification * 100%: complete reossifcation
3 secondary outcomes
Number of pain
Time frame: day 1
number of deficience
Time frame: day 1
number of complication
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 12 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Catherine CYTEVAL, MD.PhD study director
University Hospital, Montpellier
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 University Hospital, Montpellier 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 2 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 Oct 2021. 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?
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?
Difference of size lesion after treatement (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 12 Oct 2021.