Vertebra Compression FractureCIMVERNCT06174077
Monitoring of Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Procedures
An observational study of Vertebra Compression Fracture, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebra Compression Fracture
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2020to 31 Dec 2023
- 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: Adult patient (≥18 years old) cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level
Who may be able to join
- Adult patient (≥18 years old)
- Man or woman
- Patient cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level between 01/06/2020 and 30/09/2020
- Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.
Who cannot join
- Patient who expressed their opposition to the reuse of their data for research purposes
- Vertebroplasties of more than one level
- History of spinal surgery or vertebroplasty near the level concerned
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Imagerie Interventionnelle - CHU de Strasbourg - France
Strasbourg, 67091
Roberto Luigi CAZZATO, MD, 33 3 69 55 16 35, robertoluigi.cazzato@chru-strasbourg.fr
Roberto Luigi CAZZATO, MD
About this study
Official title: Interest of Continuous Monitoring of the Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Gestures With a Flat Panel Detector
The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation.
The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection
- Conditions
- Vertebra Compression Fracture
- Keywords
- Vertebra Compression Fracture, Vertebral cementoplasty, Fluoroscopy time, Fluoroscopic control, Single-level vertebral cementoplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start6 Oct 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebra Compression FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174077
- Sponsor's protocol ID
- 7993
- Acronym
- CIMVER
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2022
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Continuous Monitoring of the Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Gestures With a Flat Panel Detector
- ClinicalTrials.gov ID
- NCT06174077
- Acronym / sponsor ID
- CIMVER / 7993
- Conditions
- Vertebra Compression Fracture
- Keywords
- Vertebra Compression Fracture, Vertebral cementoplasty, Fluoroscopy time, Fluoroscopic control, Single-level vertebral cementoplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Dec 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.
The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation.
The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old)
- Man or woman
- Patient cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level between 01/06/2020 and 30/09/2020
- Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.
Key exclusion criteria (3 listed)
- Patient who expressed their opposition to the reuse of their data for research purposes
- Vertebroplasties of more than one level
- History of spinal surgery or vertebroplasty near the level concerned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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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.
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 Vertebra Compression Fracture, 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 4 inclusion and 3 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 18 Dec 2023. 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 Roberto Luigi CAZZATO, MD (33 3 69 55 16 35, robertoluigi.cazzato@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control (time frame: up to 1 month). 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 18 Dec 2023.