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Trial intelligence / Profile preview
Mediclore in endoscopic lumbar discectomy
NCT06034041Phase 4
Key facts
- Status
- Unknown
- Start
- Oct 2023
- Primary completion
- Mar 2024
- Countries
- 1
- Modality
- Polymer-based Nanoparticles, Device-based Delivery
- Drugs
- Mediclore
- Conditions
- epidural fibrosis
01
Overview
Phase 4, randomised, single-blind trial of Mediclore in epidural fibrosis (2 arms). Primary endpoint: Visual Analogue Scale for Leg pain at 3 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Mediclore
1.5 CC of Mediclore applied at surgical site
Control
1.5 CC of Normal Saline applied at surgical site
03
Who it enrols
Patients with lumbar disc herniation who failed conservative treatment for more than 6 months. Excludes patients with previous lumbar surgery, epidural steroid injections, infection, malignancy, or allergy to components.
04
Endpoints
Primary
Visual Analogue Scale for Leg pain
Secondary
Visual Analogue Scale for Back pain
Visual Analogue Scale for Leg pain
Oswestry Disability Index
EuroQol-5 Dimension-5 Level
Amount of Epidural Fibrosis
Complication rate
Straight leg raising test result
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