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NCT06461676 · ClinicalTrials.gov registry record · Phase 1
Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)
A Phase 1 study, sponsored by Emory University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT06461676 is a Phase 1 study that has not yet begun recruiting, run by Emory University. The registered enrollment target is 12 participants.
The verdict
NCT06461676, a Phase 1 study, has not yet begun recruiting, sponsored by Emory University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS). The main questions it aims to answer are: * Whether VentriGel is safe in treating patients with HLHS * Whether there are any preliminary improvements in measures of cardiac function following Ventrigel injection
Interventions
- DRUG Ventrix Bio Extracellular Matrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-08 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06461676
The ClinicalTrials.gov registry entry for NCT06461676 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ventrix Bio Extracellular Matrix is the first listed.
NCT06461676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06461676 about?
NCT06461676 is a clinical study titled "Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)". The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS). The main questions it aims to answer are: * Whether VentriGel is safe in treating patients with HLHS * Whether there are any prelim...
What is the current status of trial NCT06461676?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-08. Estimated completion is 2028-09.
What interventions are being tested in trial NCT06461676?
The interventions under investigation include: Ventrix Bio Extracellular Matrix (DRUG).
Who is sponsoring clinical trial NCT06461676?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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