NCT04931212

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.4 years

First QC Date

February 6, 2021

Last Update Submit

November 17, 2025

Conditions

Congenital Diaphragmatic Hernia

Keywords

Congenital diaphragmatic herniaFetal endoscopic tracheal occlusionSmart-TO balloonProof of conceptSafety study

Outcome Measures

Primary Outcomes (2)

  • Deflation of the Smart-TO balloon after exposure to the fringe field of the MRI

    No visualization of the balloon at ultrasound scan

    Between 34 and 34+6 amenorrhea weeks

  • Expelling of the Smart-TO balloon outside the airways

    Thorax X-ray of the neonate

    At birth

Secondary Outcomes (8)

  • Serious unexpected or adverse reactions

    From date of inclusion until discharge date from hospitalization of newborn, up 15 months

  • Spontaneous deflation of the balloon

    Between the FETO (27amenorrhea weeks) and the unplug procedure (34 amenorrhea weeks)

  • Prematurity

    At birth

  • Preterm premature rupture of the membranes (PPROM)

    from date of inclusion until delivery, up to 37 amenorrhea weeks

  • Fetal lung growth

    Before the unplug procedure

  • +3 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL
Procedure: FETO with Smart-TO balloon

Interventions

FETO with Smart-TO balloonPROCEDURE

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

Also known as: Unplug
Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or more, who are able to consent, and affiliated to social security
  • Singleton pregnancy with fetus with isolated left-sided congenital diaphragmatic hernia (no additional malformation nor chromosomal abnormality) and:
  • Severe pulmonary hypoplasia defined as observed on expected 'lung-to-head ration' (O/E LHR) \<25% irrespective of the liver position as measured between 27wks and 29wks + 6 days Or Moderate pulmonary hypoplasia defined as O/E LHR 25-34.9% (liver up or down) or O/E LHR 35-44.9% with liver up as measured between 30wks and 31wks + 6 days

You may not qualify if:

  • Maternal contraindication to fetoscopic surgery
  • Preterm premature rupture of the membranes (PPROM) or condition strongly predisposing to PPROM or premature delivery
  • Impossibility of remain close to the FETO center during the fetal occlusion period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Béclère

Clamart, 92140, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Anne-Gael CORDIER, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Nicolas SANANES, MD, PhD

    University Hospital, Strasbourg, France

    STUDY CHAIR

  • Alexandra BENACHI, MD, PhD

    AH-HP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2021

First Posted

June 18, 2021

Study Start

August 4, 2021

Primary Completion

January 14, 2024

Study Completion

September 5, 2024

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)