The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysacharide in normal saline solution. The device intended use is to help treat back pain by lubricating fascia.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2023
- Device: Fascigel
- The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysacharide in normal saline solution.
Arms, Groups and Cohorts
- Experimental: Fascigel injection application
- Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.
Clinical Trial Outcome Measures
- – Pain management
- Time Frame: 3 months
- VAS scale
Participating in This Clinical Trial
- Back pain (VAS above 4 cm) – Limited range of motion – Duration of pain for over 3 months – Patient willing and able to provide the written consent – Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study Exclusion Criteria:
- State after back surgery – BMI > 35 – Age < 18 years – Pregnant or lactating woman – Patient in terminal stage of living – Patient with known hypersensitivity or allergy to any of substances contained in Medical Device – Patient participating in the intervention clinical study – Alcohol or drug abuse – Patient undergoing chronic coagulation therapy
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Contipro Pharma a.s.
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Pavel Kušnierik, +420775 418 823, firstname.lastname@example.org
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.