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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 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.

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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.

Conditions Studied

Congenital Diaphragmatic Hernia

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

FieldValue
Enrollment Target 10 participants
Start Date 2021-04-05
Est. Completion 2028-06
Phase NA

Sponsor

Dr Erin Perrone

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04052828

The ClinicalTrials.gov registry entry for NCT04052828 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower). The listed sponsor is Dr Erin Perrone, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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