Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe

Overview

The conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). The purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments (surgery, injection, rehabilitation, etc.). Women requiring pelvic MRI may participate in the study. The pelvic dynamic MRI will be done with an intravaginal probe which will be inserted by the patient herself as well as gel in the anus and vagina which will allow to obtain the data on the characteristics of the pelvic tissues of each woman with a 3D reconstruction.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2024

Interventions

  • Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor
    • Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel

Arms, Groups and Cohorts

  • Experimental: Dynamic pelvic MRI

Clinical Trial Outcome Measures

Primary Measures

  • 3D reconstruction of the pelvic cavity
    • Time Frame: at 1 month
    • Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe.

Participating in This Clinical Trial

Inclusion Criteria

All:

  • Understanding of the French language – Signature of informed consent – Insured social patient For pregnant women: – Primiparous women – with no severe maternal-fetal pathology – with no scheduled caesarean section at the time of the MRI For women with prolapse: – Requires pelvic MRI Exclusion Criteria:

  • Minor – Person who does not have social security – Person with ongoing vaginal infection – Pregnant woman during the first or third trimester of pregnancy – Pregnant woman with broken water pocket – Bi-cicatricial uterus – IVF – Person wearing a pace maker or any intra-body metal implant (if "tube" MRI) – Claustrophobic person (if "tube" MRI)

Gender Eligibility: Female

The recruitment of patients will be done during a consultation within the Obstetric Gynecology Department CHU of Lille to select those requiring a pelvic MRI.

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michel COSSON, MD,PhD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Michel COSSON, MD,PhD, 03 20 44 65 84, michel.cosson@chru-lille.fr

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