BridgeMD
Tests treatment safety and results for Lumbar Spinal Stenosis
Official title Safety and Effectiveness Evaluation of Spinal Laminectomy Robot
ClinicalTrials.gov ID: NCT06593574
What this study is testing
- What it's testing
- The purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
- Patients with complete clinical data, willing and able to sign informed consent;
- Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications...
- Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:
- It was not effective after 3 months of conservative treatment
You likely can't join if
- Patients who are not suitable for robot-assisted surgery;
- Patients with existing implants in or near the vertebral body of the lesion;
- Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
- Pregnant and lactating female patients;
- the subject is unwilling or unable to restrict activities or follow medical advice;
- Patients with infection near the focal area;
See the full eligibility criteria
- Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
- Patients with complete clinical data, willing and able to sign informed consent;
- Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal laminectomy and undergoing open surgery；
- Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:
- It was not effective after 3 months of conservative treatment
- Symptoms seriously affect the quality of life
- cauda equina nerve injury
- Lumbar spondylolisthesis occurs in one of the following:
- Symptoms of II° and below slip were not relieved by non-surgical treatment
- Lumbar spondylolisthesis III° and above
- Symptoms of lumbar spinal stenosis
- The TLISS score of lumbar spine fracture is greater than or equal to 4 points.
- Patients who are not suitable for robot-assisted surgery;
- Patients with existing implants in or near the vertebral body of the lesion;
- Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
- Pregnant and lactating female patients;
- the subject is unwilling or unable to restrict activities or follow medical advice;
- Patients with infection near the focal area;
- The patient is mentally incapable or unable to understand the requirements for participating in the study;
- The patient is critically ill, the expected survival period is not more than 2 years, and it is difficult to make an accurate assessment of the how well it works and safety of the device;
- Patients with coagulation dysfunction;
- Other researchers did not consider it suitable for admission.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Guangzhou, China
- Hangzhou, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Guangzhou, China; Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.