Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT02986087
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Diaphragmatic Hernia
  • Pulmonary Hypoplasia
  • Pulmonary; Hypertension

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Fetal Tracheal Occlusion — DEVICE
    Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of \<25%, LHR \<1, o/e LHR\<30% (moderate), singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days, no maternal disease, maternal age \> 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.

Study Details

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Key Dates

Start date
Nov 30, 2016
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fetal Tracheal Occlusion
    Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

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, MD
[email protected]
513-803-5270
Jose L Peiro, MD, PhD, MBA
[email protected]
513-803-4563
Jose L Peiro, MD, MBA (SUB_INVESTIGATOR)
Foong Y Lim, MD (PRINCIPAL_INVESTIGATOR)

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

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