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An Ultrasound Guided Automated Spinal Landmark Identification System

Study acronym: uSINE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 7, 2026 (before its estimated October 14, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv12
  2. Primary completion date: Oct 14, 2023 to Oct 14, 2026
    • Study completion date: Dec 31, 2023 to Dec 31, 2027
    v11
  3. Primary completion date: Oct 14, 2022 to Oct 14, 2023
    • Study completion date: Dec 31, 2022 to Dec 31, 2023
    v10
  4. Re-verified, no change to tracked fieldsv9
  5. Primary completion date: Oct 14, 2021 to Oct 14, 2022
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Dec 31, 2021 to Oct 14, 2021v7
  2. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Dec 31, 2020 to Dec 31, 2021
    • Site details revised
    v6
  3. Enrollment target: 50 to 200v5 Show 5 more changesShow less
    • Primary completion date: Feb 14, 2019 to Dec 31, 2020
    • Study completion date: Oct 31, 2020 to Dec 31, 2021
    • Eligibility criteria revised
    • Study description expanded, about 35 words
    • Study title shortened, about 5 words
  4. Primary completion date changed from estimate of Dec 31, 2019 to Feb 14, 2019
    • Study completion date: Mar 30, 2020 to Oct 31, 2020
    v4
  5. Primary completion date: Aug 31, 2019 to Dec 31, 2019
    • Study completion date: Nov 30, 2019 to Mar 30, 2020
    v3
  6. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 70 to confirmed 50
    • Primary completion date: May 31, 2019 to Aug 31, 2019
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neuraxial ultrasonography has been shown a safe and effective technique to enhance the overall success rate of lumbar puncture and reduce the number of injection attempts. However, the current blind palpation landmark technique is known to be highly inaccurate and may increase the risk of multiple insertion attempts, patient suffering and complication rates such as spinal cord injury. Various clinical studies have confirmed the effectiveness of ultrasound imaging compared with the traditional palpation method. However, none of the present system can achieve real-time guidance. The overall aim of this proposal is to develop an ultrasound guided automated spinal landmark identification with real-time neuraxial needle insertion system (uSINE) to improve patient safety and efficacy of neuraxial procedure needle insertion success. This will be achieved in 4 phases of technology development and clinical trial phases. The investigators will recruit 20 subjects in a prospective cohort study to investigate the spinal needle first attempt success rate as a clinically relevant outcome. The secondary aim is to develop an automated spinal landmark identification algorithm using image processing to identify spinal landmarks in 50 obese patients. Third phase objective will be to obtain clinical data, and evaluation and annotation of the clinical data of spinal ultrasonography in 65 obese patients (BMI \> 30kg/m2), whereas the fourth phase will measure the uSINE identification accuracy and first-attempt puncture success rate of uSINE in a clinical study of 65 obese patients (BMI \> 30kg/m2).
Trial Details
NCT Number NCT03687411
Lead Sponsor KK Women's and Children's Hospital
Conditions
(from sponsor)		 Spinal Anaesthesia, Obesity
Related terms Obesity
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov