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NCT06095531
A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
NA trial testing Tetranite for Cranial Flap Fixation (TN-CFF) in Craniotomy in 20 participants. Participants enrolled and being followed up; not accepting new ones.
8 December 2025
Quick facts
| Lead sponsor | RevBio |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 18 April 2024 |
| Primary completion | 8 December 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Tetranite for Cranial Flap Fixation (TN-CFF)
Conditions studied
- Craniotomy — all drugs for Craniotomy →
Sponsor
RevBio — full company profile →
Who can join
Adults 18 to 75, any sex, with Craniotomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Demonstration of the safety of a regenerative bone adhesive for cranial flap fixation in a 12-week clinically relevant sheep model.
Smith TR, Lazor JB, Slotkin JR, Woodard EJ, et al · · 2026 · PMID 41569731 · DOI 10.3171/2025.8.jns243158
Verify or expand the search:
- PubMed search for NCT06095531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tetranite for Cranial Flap Fixation (TN-CFF)
Trials testing the same drug.
- NCT06780852 — A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive · NA · recruiting
Other recruiting trials for Craniotomy
Currently open trials in the same condition.
- NCT06993922 — Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management · NA · recruiting
- NCT06780852 — A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive · NA · recruiting
- NCT07399093 — Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia · recruiting
- NCT05851989 — Study on Prognosis of Acutely Ruptured Intracranial Aneurysms · recruiting
- NCT04229966 — Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases · recruiting
Other RevBio trials
Trials by the same sponsor.
- NCT07452549 — Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware · NA · not yet recruiting
- NCT07452536 — A Pilot Clinical Study to Evidence Safety and Efficacy of Fracture Fixation of the Distal Radius Using a Bioresorbable B · NA · not yet recruiting
- NCT06780852 — A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive · NA · recruiting
- NCT05535426 — Feasibility Study to Assess Outcomes of Immediately Inserted and Restored Dental Implants Using pH-modified Tetranite · NA · unknown
- NCT04121364 — Immediate Placement and Stabilization of Dental Implants With Tetranite Stabilization Material in Mandibular and Maxilla · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06095531 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RevBio
- Last refreshed: 4 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06095531.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing