Recruiting

Fetal Endoscopic Tracheal Occlusion

Sponsor:

UCLA

Code:

NCT05421676

Conditions

Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

Study Details

Brief summary:

This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at UC Davis Medical Center. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at UC Davis Medical Center.

This study requires that study participants live within 30 minutes of the UC Davis Medical Center in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.

Conditions

Congenital Diaphragmatic Hernia

Study ID

NCT05421676

Start date

Feb 12, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
3. Pregnant women, age 18 years and older
4. Singleton pregnancy
5. No pathogenic variants on microarray or pathologic findings on karyotype
6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
7. Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25% with liver up
8. 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
9. Meets psychosocial criteria

  • Willing to reside within 30 minutes of UC Davis Medical Center and ability to maintain follow up appointments
  • 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 the UC Davis Medical Center.
  • Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

Exclusion Criteria:

1. Adults unable to consent
2. Prisoners
3. Multi-fetal pregnancy
4. History of latex allergy
5. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (<20mm), or uterine anomaly predisposing to preterm labor
6. Psychosocial ineligibility

  • Inability to reside within 30 minutes of UC Davis Medical Center or inability to maintain follow up appointments
  • Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
7. Bilateral CDH, unilateral CDH with o/e LHR > 25% or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
8. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
9. Maternal contraindications to elective fetoscopic surgery
10. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
11. Maternal isoimmunization or neonatal alloimmune thrombocytopenia
12. Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
13. No safe or feasible fetoscopic approach to balloon placement

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FETO with GOLDBAL2

A balloon will be placed in the airway of the fetus during the FETO procedure.

Interventions

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.

Primary outcome measure

  • Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation. [ Time Frame: 27 weeks 0 days to 29 weeks 6 days ]
  • Number of successful retrievals of the GOLDBAL2 [ Time Frame: Removal prior to delivery approximately 34 weeks of gestation ]

Central Contacts and Locations

Central contacts

Amy Powne, MSN, RN

916-717-4690fctc@ucdavis.edu

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Amy Powne, MSN, RN

916-717-4690fctc@ucdavis.edu

Principal Investigator:

Shinjiro Hirose, MD

More Information

Sponsor

University of California, Davis

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Congenital Diaphragmatic Hernia
  • Fetal endoscopic tracheal occlusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-12-15.