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NCT05421676 · ClinicalTrials.gov registry record · NA

Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

A NA study of Congenital Diaphragmatic Hernia, sponsored by University of California, Davis.

Recruiting
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT05421676 is a NA study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by University of California, Davis. 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

NCT05421676, a NA study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by University of California, Davis.

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 UC Davis Medical Center. 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 UC Davis Medical Center. This study requires that study participants live within 30 minutes of the UC Davis Medical Center 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)

California

  • UC Davis Medical Center - Sacramento

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2024-02-12
Est. Completion 2027-12
Phase NA

Sponsor

University of California, Davis

657 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05421676

The ClinicalTrials.gov registry entry for NCT05421676 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 University of California, Davis, which has 657 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.

NCT05421676 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05421676 about?

NCT05421676 is a clinical study titled "Fetal Endoscopic Tracheal Occlusion for CDH (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 UC Davis Medical Center. The study will enroll pregnan...

What is the current status of trial NCT05421676?

This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2024-02-12. Estimated completion is 2027-12.

What conditions does trial NCT05421676 study?

This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.

What interventions are being tested in trial NCT05421676?

The interventions under investigation include: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) (DEVICE).

Who is sponsoring clinical trial NCT05421676?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05421676 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.