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NCT04434729 · ClinicalTrials.gov registry record · NA
Fetal Treatment of Galenic Malformations
A NA study of Vein of Galen Malformations, sponsored by Darren Orbach.
- Active
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT04434729 is a NA study of Vein of Galen Malformations that is active but no longer recruiting, run by Darren Orbach. The registered enrollment target is 7 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04434729, a NA study of Vein of Galen Malformations, is active but no longer recruiting, sponsored by Darren Orbach.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, single-arm non-randomized interventional study of fetuses to assess the safety and efficacy of fetal embolization of Vein of Galen Malformation (VOGM). Subjects will receive a one-time study intervention of fetal embolization. Follow-up assessments will be collected every 4 weeks until delivery, as per standard of care. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
Conditions Studied
Interventions
- DEVICE Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2026-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04434729
The ClinicalTrials.gov registry entry for NCT04434729 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Darren Orbach, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Vein of Galen Malformations appearing as the primary indexed condition, and to 1 intervention - of which Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils is the first listed.
NCT04434729 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04434729 about?
NCT04434729 is a clinical study titled "Fetal Treatment of Galenic Malformations". This is a prospective, single-arm non-randomized interventional study of fetuses to assess the safety and efficacy of fetal embolization of Vein of Galen Malformation (VOGM). Subjects will receive a one-time study intervention of fetal embolization. Follow-up assessments will be collected every 4 we...
What is the current status of trial NCT04434729?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 7 participants. The study started on 2022-09-30. Estimated completion is 2026-08.
What conditions does trial NCT04434729 study?
This clinical trial studies the following conditions: Vein of Galen Malformations.
What interventions are being tested in trial NCT04434729?
The interventions under investigation include: Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils (DEVICE).
Who is sponsoring clinical trial NCT04434729?
This trial is sponsored by Darren Orbach, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04434729 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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