Back to resultsDevelopment of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe (MI-IRM)
Primary Purpose
Pelvic Floor Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic pelvic MRI with intravaginal probe with pressure sensor
Sponsored by
About this trial
This is an interventional diagnostic trial for Pelvic Floor Disorders focused on measuring Geometrical reconstruction, Pelvic Floor Disorders, FE models, Pelvic system, MRI
Eligibility Criteria
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)
Sites / Locations
- Hôpital Jeanne de Flandres, CHURecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynamic pelvic MRI
Arm Description
Outcomes
Primary Outcome Measures
3D reconstruction of the pelvic cavity
Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe.
Secondary Outcome Measures
Full Information
NCT ID
NCT04319653
First Posted
March 20, 2020
Last Updated
March 1, 2022
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT04319653
Brief Title
Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
Acronym
MI-IRM
Official Title
Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Geometrical reconstruction, Pelvic Floor Disorders, FE models, Pelvic system, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dynamic pelvic MRI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Dynamic pelvic MRI with intravaginal probe with pressure sensor
Intervention Description
Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel
Primary Outcome Measure Information:
Title
3D reconstruction of the pelvic cavity
Description
Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe.
Time Frame
at 1 month
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
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 & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel COSSON, MD,PhD
Phone
03 20 44 65 84
Ext
+33
Email
michel.cosson@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel COSSON, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jeanne de Flandres, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Cosson, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
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