Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05100693

Smart Removal for Congenital Diaphragmatic Hernia

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2021-10-29

25

Participants Needed

1

Research Sites

268 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia.

CONDITIONS

Official Title

Smart Removal for Congenital Diaphragmatic Hernia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women carrying a fetus with isolated congenital diaphragmatic hernia (CDH) eligible for FETO with severe or moderate lung underdevelopment
  • Left-sided CDH with severe lung hypoplasia (lung-to-head ratio under 25%)
  • Left-sided CDH with moderate lung hypoplasia (lung-to-head ratios 25 to 34.9% with any liver position, or 35 to 44.9% with liver herniation)
  • Right-sided CDH with severe lung hypoplasia (lung-to-head ratio under 50%)
  • Voluntary written informed consent obtained before screening
  • Maternal age 18 years or older
  • Single pregnancy
  • Signed informed consent
  • Consent to have an ultrasound of the uterus after delivery if needed
  • Agreement from the postnatal management center to participate
Not Eligible

You will not qualify if you...

  • Allergy to latex
  • Contraindications to fetoscopy and FETO due to maternal diseases or technical issues
  • Premature rupture of membranes (PROM)
  • Multiple pregnancy
  • Maternal age under 18 years
  • Refusal to stay near the UZ Leuven center until balloon removal
  • Any condition that might risk participant safety or protocol compliance as judged by the investigator
  • Prior or current treatments that might risk participant safety or affect trial integrity
  • Participation in another interventional trial involving an investigational drug or device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

J

Jan Depret, PhD, MD

CONTACT

D

David Basurto, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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