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ACTIVE NOT RECRUITING NA

A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive

NCT06095531 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 20 participants
Start Date 2024-04-18
Est. Completion 2026-06-30
Phase NA

Sponsor

RevBio

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06095531

The ClinicalTrials.gov registry entry for NCT06095531 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RevBio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06095531 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06095531?

The interventions under investigation include: Tetranite for Cranial Flap Fixation (TN-CFF) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06095531?

This trial is sponsored by RevBio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial