Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mauro H. Schenone
Study ID
NCT05962346
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

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

Interventions

  • BALT GOLDBALL 2 detachable latex ballon — DEVICE
    Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
  • BALTACCIBDPE100 Microcatheter — DEVICE
    Used to deliver the detachable balloon
  • Storz fetoscopic operating sheath and miniature telescope/fetoscope — DEVICE
    Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.

Study Details

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

Key Dates

Start date
Dec 31, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2043
Completion
Jul 31, 2043

Study Design

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

Arms

  • Experimental: FETO Group
    Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.

Primary Outcome Measure

Technical success of the balloon placement procedure [ Time Frame: Up to 29 weeks gestation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905
Mauro H. Schenone, MD
507-293-4390

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By research site
Mayo Clinic Minnesota· Rochester, MN

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