Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Part of paid clinical trials in Miami, Florida.

Sponsor
Rodrigo Ruano
Study ID
NCT03138863
Status
Recruiting
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Conditions

  • Congenital Diaphragmatic Hernia
  • Pulmonary Artery Hypertension
  • Pulmonary Hypoplasia

Eligibility Criteria

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

Interventions

  • BALT GoldbBAL2 Detachable Balloon — DEVICE
    Latex balloon, with radio-opaque inclusion
  • Catheter System — DEVICE
    100 cm tapered micro-catheter

Study Details

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

Key Dates

Start date
May 1, 2024
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
Nov 1, 2030

Study Design

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

Arms

  • Experimental: FETO Group
    Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.

Primary Outcome Measure

Number of successfully completed FETO procedures [ Time Frame: Up to 34 weeks gestation ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Rodrigo Ruano, MD, Ph.D
[email protected]
305-689-8001
Rodrigo Ruano, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLMayo Clinic· Rochester, MN

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