Pelvic DeformityDYNPELVISNCT06577831
Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI
A study testing dynamic MRI in people with Pelvic Deformity, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood. The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Deformity
- What is being tested?
- dynamic MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2022to 24 Feb 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women, +/- of childbearing age, with or without effective contraception.
- Informed consent signed prior to any procedure described in the study.
Who cannot join
- Contraindication to MRI,
- Impossibility of performing the examination during thrust,
- Minor patients
- Pregnant or breast-feeding women,
- Women of legal age under guardianship
- Persons staying in a health or social institution,
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- People in emergency situations,
- Persons not covered by a social security scheme,
- Persons deprived of their liberty.
- Specifically, women with IUDs will be excluded if they cannot remove them before the examination.
- For healthy volunteers: history of colorectal surgery.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hopitaux de Marseille _ Hopital de la Timone
Marseille, France, 13005
About this study
Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.
The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.
Read more
This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.
The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.
The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.
- Conditions
- Pelvic Deformity
- Being tested
- dynamic MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic MRIDiagnostic test
- MRI sequences will be performed for patients and healthy volunteers i
- Vaginal and rectal tagging will be performed using a water-based ultrasound gel.
- The gel will be inserted by an authorized person (nurse or doctor) using a syringe with a conical tip and, optionally, a probe.
- MRI sequences.
- Data analysis and interpretation.
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | Patients requiring dynamic MRI for the diagnosis of pelvic static disorders Receives: Diagnostic Test: dynamic MRI |
| control | Active comparator | Healthy volunteers for a dynamic MRI Receives: Diagnostic Test: dynamic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.
a metric for displacement of the anchor points of the targeted pelvic organs will be evaluated
Measured: 0 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start25 Feb 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic DeformityStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577831
- Sponsor's protocol ID
- RCAPHM20_0016
- Acronym
- DYNPELVIS
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2024
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI
- ClinicalTrials.gov ID
- NCT06577831
- Acronym / sponsor ID
- DYNPELVIS / RCAPHM20_0016
- Conditions
- Pelvic Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 29 Aug 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.
Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.
The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.
This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.
The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.
The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Diagnostic Test: dynamic MRIPatients requiring dynamic MRI for the diagnosis of pelvic static disorders |
| control | Active comparator | Diagnostic Test: dynamic MRIHealthy volunteers for a dynamic MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult women, +/- of childbearing age, with or without effective contraception.
- Informed consent signed prior to any procedure described in the study.
Key exclusion criteria (11 listed)
- Contraindication to MRI,
- Impossibility of performing the examination during thrust,
- Minor patients
- Pregnant or breast-feeding women,
- Women of legal age under guardianship
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 |
|---|---|---|
| dynamic MRI* MRI sequences will be performed for patients and healthy volunteers i * Vaginal and rectal tagging will be performed using a water-based ultrasound gel. * The gel will be inserted by an authorized person (nurse or doctor) using a syringe with a conical tip and, optionally, a probe. * MRI sequences. * Data analysis and interpretation. | Diagnostic test | control, patient |
Primary outcome
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.
Time frame: 0 month
a metric for displacement of the anchor points of the targeted pelvic organs will be evaluated
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 20 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic MRI in people with Pelvic Deformity, run by Assistance Publique Hopitaux De Marseille 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 2 inclusion and 11 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 20 Nov 2025. 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?
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI. (time frame: 0 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 20 Nov 2025.