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A multicenter randomized, single-blind, parallel controlled clinical trial for evaluating the safety and efficacy of the Minimally Invasive Surgery System for spinal surgery

A multicenter randomized, single-blind, parallel controlled clinical trial for evaluating the safety and efficacy of the Minimally Invasive Surgery System for spinal surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014967
Enrollment
Unknown
Registered
2018-02-25
Start date
2018-01-15
Completion date
Unknown
Last updated
2018-03-05

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

Conditions

lumbar disc herniation/spinal canal stenosis

Interventions

Test Group:to finish the operation by Minimally Invasive Surgery System
Control Group:use conventional method to finish operation

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old male and female; 2. The patients need to have a surgery operation which can be performed by the way of open or minimally invasive; 3. Sign on the informed consent and agree to participate in this trial; 4. finish screening test and meet all screening conditions.

Exclusion criteria

Exclusion criteria: 1. Patients who do not meet all of the screening conditions; 2. Metal allergy; 3. Women who are lactating or pregnant, or cannot exclude the possibility of pregnancy; 4. Patients with coagulation dysfunction; 5. Patients who need secondary surgery for treatment because of failure of spinal surgery; 6. Patients who have spinal tumor, deformity or slide; 7. In the last 3 months, Patients who have participated in other drugs, medical devices and other related clinical trial ; 8. The researcher considers that it is inappropriate for the patients to participate in the test.

Design outcomes

Primary

MeasureTime frame
Insertion deviation of Kirschner wire;

Secondary

MeasureTime frame
accumulative exposure time of X-ray;accumulative exposure times of X-ray;

Countries

China

Contacts

Public ContactZhongjun Liu

Peking University Third Hospital

liuzj@medmail.com.cn+86 010-82266699

Outcome results

None listed

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