Fetal Endoscopic Tracheal Occlusion (FETO) Trial for 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, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

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

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study

• Pregnant women, age 18 years and older

• Singleton pregnancy

• No pathogenic variants on microarray or pathologic findings on karyotype; results by fluorescence in situ hybridization (FISH) will be acceptable if patient is \>26 weeks

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

• Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \<25% with liver up

• Gestational age at FETO procedure: if o/e LHR \<25%, will be done at 27 weeks plus 0 days to 29 weeks plus 6 days

• Meets psychosocial criteria

‣ Willing to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) and ability to maintain follow up appointments. NYP/CUIMC will work with the study participant to assist in securing housing 30 minutes from the hospital if this is a challenge to her.

⁃ Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC)

⁃ Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

Locations
United States
New York
Columbia University Irving Medical Center/NewYork-Presbyterian
RECRUITING
New York
Contact Information
Primary
Amanda Alonso, MHA
aa2974@cumc.columbia.edu
212-342-0261
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-06
Participants
Target number of participants: 10
Treatments
Experimental: Treatment
GOLDBAL2 balloon will be placed for Fetus diagnosed with Congenital diaphragmatic hernia (CDH) at Gestational age of 27w0d - 29w6d and retrieved at Gestational age of 34w0d to 34w 6 days
Sponsors
Leads: Vincent Duron

This content was sourced from clinicaltrials.gov