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Exploring the effectiveness and safety of real-time acquisition of spatial position information of spinal segments based on ultrasound imaging

Exploring the effectiveness and safety of real-time acquisition of spatial position information of spinal segments based on ultrasound imaging

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088339
Enrollment
Unknown
Registered
2024-08-15
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal fracture

Interventions

study group:Ultrasound scanning of lumbar spine under navigation

Sponsors

Shenzhen Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The patient is aged between 18 and 80 years old (including 18 and 80 years old), with no gender restrictions; (2) The patient should have symptoms related to spinal surgery; (3) Patients assessed by researchers to require lumbar spine multi-slice spiral CT scanning; (4) The subjects fully understand the benefits and risks of this trial and are willing to participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who cannot tolerate multi-slice spiral CT scans; (2) Patients with severe internal or surgical diseases or weak constitution who cannot tolerate examinations; (3) Patients with expected poor compliance; (4) Pregnant or lactating women, or patients with fertility plans during clinical studies; (5) The patient has participated in clinical trials of other drugs within the past 3 months prior to enrollment, or in clinical trials of other devices within the past 1 month prior to enrollment;

Design outcomes

Primary

MeasureTime frame
Accuracy of ultrasound 3D image localization;

Secondary

MeasureTime frame
Success rate of ultrasound image localization;Ultrasound image localization rate;Ultrasound image localization time;Incidence and number of adverse events;The incidence and number of device defects;Expected adverse time occurrence rate;

Countries

China

Contacts

Public ContactHongxun Sang

Shenzhen Hospital of Southern Medical University

hxsang@fmmu.edu.cn+86 139 9196 3991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026