# The Paediatric EVICEL® Neuro Study

> **NCT02309645** · PHASE3 · TERMINATED · sponsor: **Ethicon, Inc.** · enrollment: 40 (actual)

## Conditions studied

- CSF Leak

## Interventions

- **BIOLOGICAL:** EVICEL® Fibrin Sealant
- **OTHER:** Sutures Only

## Key facts

- **NCT ID:** NCT02309645
- **Lead sponsor:** Ethicon, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2014-10-01
- **Primary completion:** 2021-08-17
- **Final completion:** 2021-09-17
- **Target enrollment:** 40 (ACTUAL)
- **Why stopped:** Study completed the required elements (40 paediatric subjects) per regulatory requirement. The study enrolled 40/42 subjects. No safety signals were identified. No changes required to the statistical analysis as described in the protocol.
- **Last updated:** 2023-07-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02309645

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02309645, "The Paediatric EVICEL® Neuro Study". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT02309645. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*