RadiationPELVI-EOSNCT02834897
Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner
A study testing EOS and CT Exam in people with Radiation and Obstetric Labor Complications, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation, Obstetric Labor Complications, Pregnancy Complications
- What is being tested?
- EOS and CT Exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to 12 Feb 2016
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pelviscanner indication in women
Who cannot join
- In the disqualification of another study or under the "national register of volunteers."
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner.
- Being tested
- EOS and CT Exam
- Keywords
- EOS imagery
- Medical subject headings
- Obstetric Labor Complications, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS and CT ExamRadiation
EOS and CT Examen for pregnant women in the 8th month of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| EOS and CT Exam | Experimental | EOS and CT Examen for pregnant women in the 8th month of pregnancy Receives: Radiation: EOS and CT Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement reliability index Magnin with EOS cab relative to the CT measurements
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startMay 2015
- Primary completion12 Feb 2016
- Study completion12 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiationStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sebastien AUBRY, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834897
- Sponsor's protocol ID
- P/2014/236
- Acronym
- PELVI-EOS
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner
- ClinicalTrials.gov ID
- NCT02834897
- Acronym / sponsor ID
- PELVI-EOS / P/2014/236
- Keywords
- EOS imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 12 Feb 2016 (actual)
- Study completion
- 12 Feb 2016 (actual)
- First posted
- 15 Jul 2016 (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.
The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EOS and CT Exam | Experimental | Radiation: EOS and CT ExamEOS and CT Examen for pregnant women in the 8th month of pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pelviscanner indication in women
Key exclusion criteria (1 listed)
- In the disqualification of another study or under the "national register of volunteers."
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 |
|---|---|---|
| EOS and CT ExamEOS and CT Examen for pregnant women in the 8th month of pregnancy | Radiation | EOS and CT Exam |
Primary outcome
Measurement reliability index Magnin with EOS cab relative to the CT measurements
Time frame: one months
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 18 Jul 2018.
- 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.
sebastien AUBRY, MD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS and CT Exam in people with Radiation and Obstetric Labor Complications, run by Centre Hospitalier Universitaire de Besancon 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: finished, as of the sponsor's last update on 18 Jul 2018. 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?
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?
Measurement reliability index Magnin with EOS cab relative to the CT measurements (time frame: one months). 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 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.