Non-invasive Removal of the Smart Tracheal Occlusion Device for Fetal Congenital Diaphragmatic Hernia: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To demonstrate the ability to prenatally deflate the Smart-TO balloon by the magnetic fringe field generated by an MRI scanner
研究概览
简要总结
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.
详细描述
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by impaired closure of the diaphragm. This enables abdominal viscera to herniate into the thoracic cavity, leading to hypoplastic lungs and impaired lung vasculature. Fetal lung growth may be stimulated by Fetoscopic Endoluminal Tracheal Occlusion (FETO). For left-sided CDH, there is now level I evidence that it significantly improves survival in severe cases; the effect in moderate cases is much less.
Despite its benefits, the current procedure has many disadvantages. First, there is the need for prenatal reversal of the balloon, which is invasive. In utero balloon removal re-establishes airway patency. This can be done electively at 34 weeks or earlier if required, but preferentially at least 24 hours before birth. "Unplugging" requires a second procedure and a specialist team familiar with the procedure, which is available at all times. In the most extensive series published thus far, 28% of balloon removals were in an emergency setting. The only neonatal deaths were caused by complications when balloon reversal was attempted in centers without experience or unprepared. In utero reversal of the occlusion is also an invasive procedure because it requires ultrasound-guided puncture or fetoscopy. The second procedure adds both to the fetal and maternal risks.
- Balloon removal is a difficult procedure that needs expertise.
- Prenatal balloon removal procedure can fail in 3.4% even in experienced centers.
- Balloon removal is not feasible in utero in 12.6 to 24.7% of the cases.
- Balloon removal is performed in an emergency setting in 28% of the cases.
- Balloon removal can lead to neonatal death in none well-trained centers.
- In utero balloon removal may induce delivery within one week in 25% of cases.
- Patients are requested to stay close to a FETO center for the entire duration of the tracheal occlusion, which is a burden on the family, limiting the acceptability of FETO.
The Smart-TO balloon allows remotely controlled non-invasive reversal of the occlusion. Around the balloon neck, there is a metallic cylinder and inside a magnetic ball, which acts as a valve. Deflation occurs under a strong magnetic field, as generated by a clinical MRI machine. For that, it is sufficient for the pregnant woman to walk around a clinical MRI machine. The opening of the valve induces the deflation of the balloon, which is then washed out by the fluid coming out from the lungs.
The investigators have completed the translational research that proved the safety and efficacy of this balloon for FETO and want to use this medical device for the first time in humans. The purpose of this first in-woman study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for FETO in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia. Secondary outcomes include safety parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 44.9% with intrathoracic liver herniation)
- •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
排除标准
- •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 interventional trial with an investigational medicinal product (IMP) or device
结局指标
主要结局
To demonstrate the ability to prenatally deflate the Smart-TO balloon by the magnetic fringe field generated by an MRI scanner
时间窗: Up to 34+6 weeks of pregnancy
• Deflation rate after MRI exposure, assessed through ultrasound (US) immediately after MRI exposure
次要结局
- Rate of spontaneous deflation of the balloon.(Up to 34+6 weeks of pregnancy)
- Balloon expulsion from the fetal airways after deflation.(Immediately after MRI exposure)
- Percentage of lung growth(Two weeks after FETO)
- Number of adverse events related to the balloon.(From date of inclusion until date of discharge from the hospital)
- Balloon localisation at birth(At birth)
研究者
prof. dr. Jan Deprest
Professor
Universitaire Ziekenhuizen KU Leuven