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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: Active NA study of Vein of Galen Malformations, sponsored by Darren Orbach.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The procedure is deemed safe if 1. None of the following unacceptable events occur within 7 days of fetal embolization: 1. Fetal death 2. Fetal intracranial hemorrhage, either parenchymal or extra-axial, other than petechial hemorrhage. 3. Maternal death 2. None of the following unacceptable events occur between fetal embolization and delivery: 1. Intra-procedural and post-procedural morbidity to the fetus and mother, probably related to the fetal intervention, e.g. placental abru
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 |
What the registry record for NCT04434729 still lists
NCT04434729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04434729's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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