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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2021-05-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Floor Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dynamic pelvic MRI

Group Type EXPERIMENTAL

Dynamic pelvic MRI with intravaginal probe with pressure sensor

Intervention Type DEVICE

Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel

Interventions

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Dynamic pelvic MRI with intravaginal probe with pressure sensor

Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No