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NCT06772155: SEALS-TBI
Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury
trial testing Ventriculostomy in Traumatic Brain Injuries in 292 participants. Not yet recruiting.
30 June 2027
Quick facts
| Lead sponsor | Meditech Foundation |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 292 |
| Start date | 5 July 2025 |
| Primary completion | 30 June 2027 |
| Estimated completion | 31 December 2027 |
Drugs / interventions tested
- Ventriculostomy
- Ventriculostomy + Locking Device
Conditions studied
- Traumatic Brain Injuries — all drugs for Traumatic Brain Injuries →
- Intracranial Hypertension — all drugs for Intracranial Hypertension →
Sponsor
Meditech Foundation
Who can join
Adults 18 to 70, any sex, with Traumatic Brain Injuries or Intracranial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over one year through structured telephone follow-ups. The main outcomes include functional recovery, as measured by the Glasgow Outcome Scale Extended (GOSE), and the rate of complications such as operative site infections, catheter displacement, and/or reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06772155
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Related trials
Other recruiting trials for Traumatic Brain Injuries
Currently open trials in the same condition.
- NCT07072624 — Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial) · Phase 4 · recruiting
- NCT06733025 — Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study · NA · recruiting
Other Meditech Foundation trials
Trials by the same sponsor.
- NCT07358312 — TBI- Efficacy of Steroids in Acute Vasogenic Edema · not yet recruiting
- NCT06776614 — Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury · not yet recruiting
- NCT06787040 — Beyond One Option for the Treatment of Severe Traumatic Brain Injury · 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 NCT06772155 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Meditech Foundation
- Last refreshed: 8 May 2025
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/NCT06772155.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing