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Fetoscopic Endoluminal Tracheal Occlusion (FETO) With Smart-TO

NCT04931212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-11-20

No results posted yet for this study

Summary

The purpose of this study is to make the proof of concept and to evaluate the safety of fetoscopic endoluminal tracheal occlusion (FETO) using Smart-TO device in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

PROCEDURE

FETO with Smart-TO balloon

Fetal endoscopic tracheal occlusion using the Smart-TO balloon Unplug procedure by peripheral course around the MR scanner

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Anne-Gael CORDIER, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Nicolas SANANES, MD, PhD · University Hospital, Strasbourg, France

  • Alexandra BENACHI, MD, PhD · AH-HP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-04
Primary Completion
2024-01-14
Completion
2024-09-05

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 NCT04931212 on ClinicalTrials.gov