Status:
COMPLETED
Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
Lead Sponsor:
Shin Poong Pharmaceutical Co. Ltd.
Conditions:
Intervertebral Disc Disorder
Thoracic Intervertebral Disc Disorders
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
This study was designed to evaluate the efficacy and safety of Medicurtain®, an antiadhesion barrier in patients who underwent In Situ Decompression for single level and unilateral herniated lumbar in...
Detailed Description
This study was multicenter, randomized, evaluator-blind, parallel-controlled trial. A subject aged between 20\~70 years old who was reserved for In Situ Decompression for single level and unilateral h...
Eligibility Criteria
Inclusion
- Aged between 20 \~ 70 years old
- Subject who is reserved with surgery for single-level or unilateral herniated lumbar Intervertebral disc
- Subject who is scheduled for In Situ Decompression(laparoscopic hysterectomy)
- Subject who does not respond to non-surgical treatment for at least past 6 weeks or require emergency surgery due to neural paralysis or excruciating pain
- Subject or his or her legal representative who signed and informed consent
Exclusion
- Subject with multi-level or far lateral herniated lumbar intervertebral disc
- Subject with degenerative spinal disease or scoliosis
- Subject requires spinal fusion surgery
- Subject with severe liver or kidney disease
- Subject with lymph fluid or blood coagulation disease or medicated with blood clotting drug.
- Subject on oral or non-oral anti-diabetic drug or hypoglycemic drug
- Subject with suppressed immunity or autoimmune disease
- Subject with severe systemic disease
- Subject with infectious disease or healing disorder that may prevent normal healing process after surgery.
- Subject contraindicated with MRI scanning.
- Pregnant or lactating women
- Subject participated in other clinical trial within 30 days prior to the trial
- Subject justified not eligible to participate in the trial by Investigator
- Subject undergone previous spinal surgery
- Subject treated steroid epidural injection within 2 weeks or take oral steroid within 24 hours after surgery
- Subject medicated aspirin or non-steroid anti-inflammatory drug within 7 days after surgery
- Subject received myelogram or lumbar puncture within 24 hours after surgery
Key Trial Info
Start Date :
October 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2013
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04688281
Start Date
October 11 2011
End Date
March 25 2013
Last Update
September 29 2021
Active Locations (1)
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1
Samsung Medical Center
Seoul, Gangnam-gu, Ilwon-dong 50, South Korea