Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia (CDH)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form

• Pregnant individuals age 18 years and older

• Singleton pregnancy

• No pathogenic variants on prenatal chromosomal microarray or pathologic findings on karyotype analysis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks

• Isolated left or right CDH with severe pulmonary hypoplasia with o/e LHR \<25% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)

• Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information and evaluation of first ultrasound

• Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects

• Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

‣ Willingness to reside within 30 minutes of the Chicago Institute for Fetal Health (CIFH) in the time period between the FETO placement procedure and the balloon retrieval procedure and ability to maintain follow up appointments

⁃ Subject has a support person (e.g., spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Lurie Children's

⁃ Willingness to comply with study restrictions on work, exercise, and intercourse

• Meets psychosocial criteria

Locations
United States
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Contact Information
Primary
Aimen Shaaban, MD
AShaaban@luriechildrens.org
312-227-4747
Time Frame
Start Date: 2022-09-18
Estimated Completion Date: 2027-11
Participants
Target number of participants: 10
Treatments
Experimental: FETO with GOLDBAL2
A detachable balloon will be inserted in the fetal airway during the FETO procedure.
Sponsors
Leads: Aimen F. Shaaban, MD

This content was sourced from clinicaltrials.gov