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New treatment option for Congenital Diaphragmatic Hernia
Official title Smart Removal for Congenital Diaphragmatic Hernia
ClinicalTrials.gov ID: NCT05100693
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women carrying a fetus with isolated CDH eligible for FETO, i.e. with severe or moderate hypoplasia:
- Left sided CDH with severe (i.e. quotient of observed-to-expected- lung-to-head ratio under 25%) or moderate pulmonary hypoplasia...
- Right sided CDH with severe pulmonary hypoplasia (quotient of observed-to-expected- lung-to-head ratio under 50%)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Maternal age of 18 years or older
You likely can't join if
- Participants eligible for this Trial must not meet any of the following criteria:
- History of allergy to latex
- Contraindication to fetoscopy and FETO (maternal diseases or technical limitations making prenatal surgery hazardous or impossible)
- Premature Membrane Rupture (PROM)
- Multiple pregnancy
- Maternal age less than 18 years
See the full eligibility criteria
- Women carrying a fetus with isolated CDH eligible for FETO, i.e. with severe or moderate hypoplasia:
- Left sided CDH with severe (i.e. quotient of observed-to-expected- lung-to-head ratio under 25%) or moderate pulmonary hypoplasia (observed-to-expected- lung-to-head ratios of 25 to 34.9% (any liver position), or 35 to...
- Right sided CDH with severe pulmonary hypoplasia (quotient of observed-to-expected- lung-to-head ratio under 50%)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Maternal age of 18 years or older
- Single pregnancy
- Signed informed consent
- Consent to have an ultrasound of the uterus after delivery when indicated
- Postnatal management center agrees to participate
- Participants eligible for this Trial must not meet any of the following criteria:
- History of allergy to latex
- Contraindication to fetoscopy and FETO (maternal diseases or technical limitations making prenatal surgery hazardous or impossible)
- Premature Membrane Rupture (PROM)
- Multiple pregnancy
- Maternal age less than 18 years
- Refusal to stay close to the UZ Leuven until balloon removal
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in another treatment trial with an investigational medicinal product (IMP) or device
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.