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NCT06095531 · ClinicalTrials.gov registry record · NA
A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
A NA study of Craniotomy, sponsored by RevBio.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06095531: Active NA study of Craniotomy, sponsored by RevBio.
NCT06095531 is a NA study of Craniotomy that is active but no longer recruiting, run by RevBio. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06095531, a NA study of Craniotomy, is active but no longer recruiting, sponsored by RevBio.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.
Primary Outcome
Rate of all serious adverse device and procedure related effects from the time of fixation to 6 months post - procedure
Conditions Studied
Interventions
- DEVICE Tetranite for Cranial Flap Fixation (TN-CFF)
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
Tennessee
- Semmes Murphey Clinic - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT06095531 still lists
NCT06095531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Craniotomy appearing as the primary indexed condition, and to 1 intervention - of which Tetranite for Cranial Flap Fixation (TN-CFF) is the first listed.
NCT06095531 reports a single indexed study location in Massachusetts, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06095531 about?
NCT06095531 is a clinical study titled "A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive". This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (...
What is the current status of trial NCT06095531?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-04-18. Estimated completion is 2026-06-30.
What conditions does trial NCT06095531 study?
This clinical trial studies the following conditions: Craniotomy.
What interventions are being tested in trial NCT06095531?
The interventions under investigation include: Tetranite for Cranial Flap Fixation (TN-CFF) (DEVICE).
Who is sponsoring clinical trial NCT06095531?
This trial is sponsored by RevBio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06095531 being conducted?
This trial has 2 study locations across Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Craniotomy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06095531's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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