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NCT04052828 · ClinicalTrials.gov registry record · NA
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
A NA study of Congenital Diaphragmatic Hernia, sponsored by Dr Erin Perrone.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04052828: Recruiting NA study of Congenital Diaphragmatic Hernia, sponsored by Dr Erin Perrone.
NCT04052828 is a NA study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by Dr Erin Perrone. The registered enrollment target is 10 participants, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04052828, a NA study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by Dr Erin Perrone.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine. This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.
Primary Outcome
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Conditions Studied
Interventions
- DEVICE FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-04-05 |
| Est. Completion | 2028-06 |
| Phase | NA |
What NCT04052828 shows while recruiting
NCT04052828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) is the first listed.
NCT04052828 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04052828 about?
NCT04052828 is a clinical study titled "Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)". This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant wome...
What is the current status of trial NCT04052828?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2021-04-05. Estimated completion is 2028-06.
What conditions does trial NCT04052828 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.
What interventions are being tested in trial NCT04052828?
The interventions under investigation include: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) (DEVICE).
Who is sponsoring clinical trial NCT04052828?
This trial is sponsored by Dr Erin Perrone, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04052828 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Diaphragmatic Hernia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04052828's enrollment target sits among peer trials
10 18th of 22 the lowest of 22 other Congenital Diaphragmatic Hernia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Diaphragmatic Hernia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
Safety and Efficacy of FETO in CDH: A Phase III Trial
RECRUITING · NA
-
Trial of FETO for Severe Congenital Diaphragmatic Hernia
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
RECRUITING · NA
-
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
RECRUITING · NA
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