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

NCT04770805 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-14

No results posted yet for this study

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).

Conditions

  • Sacral Myelomeningocele
  • Neural Tube Defects
  • Spina Bifida

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Lucie GUILBAUD, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2024-11-24
Completion
2025-12-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770805 on ClinicalTrials.gov