Status:
COMPLETED
A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover Designed to Assess the Effectiveness and Safety of the Gimer NeuroBlock SCS Trialing System for the Treatment of Chronic Back Pain and/or Lower Limb Pain
Lead Sponsor:
GiMer Medical
Conditions:
Chronic Pain
Low Back Pain
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing Syst...
Eligibility Criteria
Inclusion
- Age ≥ 20
- Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit.
- Subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the Visual Analogue Scale (VAS).
- Subject is willing and able to comply with the procedure and requirements of this trial.
- The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.
Exclusion
- Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:
- has the mental or psychological condition that affects pain perception or
- has difficulty performing objective pain assessment or lack of suitability for participation in the study.
- Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
- Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT \< 100,000/μl or INR \> 1.4 at screening visit.
- Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
- Subject has a current diagnosis of cancer with active symptoms.
- Subject has a known terminal illness with life expectancy less than one year.
- Subject has a systematic or local infection, which may increase study risk.
- Subject currently has an indwelling device that may pose an increased risk of infection.
- Subject is pregnant or breast feeding.
- Subject has a medical history of drug or alcohol addiction within the past 2 years.
- Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
- Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
- Subject is a prisoner.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04693650
Start Date
March 1 2021
End Date
April 1 2022
Last Update
February 27 2023
Active Locations (4)
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1
China Medical University Hospital
Taichung, Taiwan
2
Mackay Memorial Hospital
Taipei, Taiwan
3
National Taiwan University Hospital
Taipei, Taiwan
4
Veterans General Hospital-Taipei
Taipei, Taiwan