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NCT03630289 · ClinicalTrials.gov registry record · NA
Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM
A NA study of Glioblastoma and Glioblastoma Multiforme, sponsored by Northwell Health.
- Active
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03630289: Active NA study of Glioblastoma and Glioblastoma Multiforme, sponsored by Northwell Health.
NCT03630289 is a NA study of Glioblastoma and Glioblastoma Multiforme that is active but no longer recruiting, run by Northwell Health. The registered enrollment target is 12 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03630289, a NA study of Glioblastoma and Glioblastoma Multiforme, is active but no longer recruiting, sponsored by Northwell Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study assesses the safety of using tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients. The objective of the study is to demonstrate that this surgical technique is safe in a small human cohort of patients with resected newly diagnosed GBM and may improve progression-free survival (PFS).
Primary Outcome
Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at 24 hours, 7 days, 30 days, 60 days, 90 days, 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.
Conditions Studied
Interventions
- PROCEDURE Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-07-27 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What the registry record for NCT03630289 still lists
NCT03630289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (89% lower).
The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB) is the first listed.
NCT03630289 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03630289 about?
NCT03630289 is a clinical study titled "Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM". This study assesses the safety of using tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients. The objective of the study is to demonstrate that this surgical technique is safe in a small ...
What is the current status of trial NCT03630289?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2018-07-27. Estimated completion is 2026-12-31.
What conditions does trial NCT03630289 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Brain Cancer, GBM.
What interventions are being tested in trial NCT03630289?
The interventions under investigation include: Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB) (PROCEDURE).
Who is sponsoring clinical trial NCT03630289?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03630289 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03630289's enrollment target sits among peer trials
12 180th of 199 higher than 13 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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.
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