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NCT04319653 Clinical Trial

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

Pelvic Floor Disorders Clinical Trial

— MI-IRM  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04319653
Other study ID # 2018_28
Secondary ID 2019-A00560-57
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2021
Est. completion date April 2024

Study information
Verified date March 2022
Source University Hospital, Lille
Contact Michel COSSON, MD,PhD
Phone 03 20 44 65 84
Email michel.cosson@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hôpital Jeanne de Flandres, CHU Lille

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 3D reconstruction of the pelvic cavity Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe. at 1 month
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