North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07564297
Status
Enrolling By Invitation

Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Fetoscopic Endoluminal Tracheal Occlusion — DEVICE
    Mothers who chose to undergo a Fetoscopic Endoluminal Tracheal Occlusion procedure for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age.
  • Standard of Care — OTHER
    Mothers who chose to receive expectant management for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age.

Study Details

The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy

Key Dates

First listed
May 4, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
May 31, 2036
Completion
May 31, 2038

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: FETO Surgery
  • Arm: Standard of Care

Primary Outcome Measure

Number of FETO procedure complications [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
Mayo Clinic in Rochester· Rochester, MN

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