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ACTIVE NOT RECRUITING
NCT04770805
NA

In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital (Paris, France).

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2021-04-16

Completion Date

2025-12-08

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

PROCEDURE

Fetoscopy

After an exteriorization of the uterus through a laparotomy, humidified and warmed gas will be insufflated with low pressure (6 to 8mmHg mmHg). Fetoscopic repair surgery will consist in a dissection of the placode, its reintegration into the spinal canal and the closure of the lesion, through a three ports access. After fetal surgery, the gas will be exsufflated and the trocar ports will be closed. The uterus will be reintegrated before suturing the maternal abdominal wall.

Locations (1)

Service médecine foetale-Hôpital Trousseau

Paris, France