NCT06315803

Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen

Randomized Controlled Clinical Study to Validate the Clinical Accuracy and Safety of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Yi Mao · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question\[s\] it aims to answer are: * The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography. * The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster. Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score.

Conditions

• Lumbar Disc Herniation
• Percutaneous Endoscopic Lumbar Discectomy
• Three-dimension Ultrasound
• Learning Curves

Interventions

Type	Name	Description
DEVICE	Real-time 3D Xplane ultrasound	After the puncture needle is in the skin, the longitudinal section of the Xplane mode can be adjusted to keep the needle in the proposed plane.

Timeline

• Start date: 2023-06-23
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: China