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

NCT06315803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-03-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • Yi Mao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315803 on ClinicalTrials.gov