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NCT05450653 · ClinicalTrials.gov registry record · NA
Trial of FETO for Severe Congenital Diaphragmatic Hernia
A NA study of Congenital Diaphragmatic Hernia, sponsored by Aimen F. Shaaban, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05450653 is a NA study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by Aimen F. Shaaban, MD. 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.
The verdict
NCT05450653, a NA study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by Aimen F. Shaaban, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.
Conditions Studied
Interventions
- DEVICE FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-09-18 |
| Est. Completion | 2031-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05450653
The ClinicalTrials.gov registry entry for NCT05450653 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 Aimen F. Shaaban, MD, which has 1 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.
NCT05450653 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05450653 about?
NCT05450653 is a clinical study titled "Trial of FETO for Severe Congenital Diaphragmatic Hernia". This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to in...
What is the current status of trial NCT05450653?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2022-09-18. Estimated completion is 2031-11.
What conditions does trial NCT05450653 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.
What interventions are being tested in trial NCT05450653?
The interventions under investigation include: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) (DEVICE).
Who is sponsoring clinical trial NCT05450653?
This trial is sponsored by Aimen F. Shaaban, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05450653 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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