Safety and Efficacy of FETO in CDH Phase III

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07187206
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Diaphragmatic Hernia
  • Pulmonary Hypertension
  • Pulmonary Hypoplasia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • FETO, Fetal Endoluminal Tracheal Occlusion — DEVICE
    Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia

Study Details

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2032
Completion
Mar 1, 2033

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlu
    FETO balloon placement/removal
  • No Intervention: Fetuses with severe or moderate congenital diaphragmatic hernia will receive standard of care and op
    no intervention standard of care

Primary Outcome Measure

Change lung growth on prenatal imaging [ Time Frame: prenatal period up to 40 weeks gestation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical Center (CCHMC)CincinnatiOhio45229
Foong-Yen Lim
[email protected]
513-803-5270
Erin Watters
[email protected]
513-803-7024
Foong Yen Lim (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By research site
Cincinnati Children's Hospital Medical Center (CCHMC)· Cincinnati, OH

Related Studies