Assistance Publique Hopitaux de Marseille _ Hopital de la Timone
Marseille, France, 13005
Completed
NCT Number: NCT06577831
Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult women, +/- of childbearing age, with or without effective contraception.
- Informed consent signed prior to any procedure described in the study.
Exclusion criteria
- 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,
- 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.
Treatment and study plan
dynamic MRI
Diagnostic 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.
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Assistance Publique Hopitaux De Marseille
Other
Registry information
Acronym: DYNPELVIS
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 29, 2024
- Registry last updated
- Nov 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.