Multi-centre, Open-label, First-in-man Study With Fascigel Used in Adult Patients Suffered From Back Pain

Overview

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

  • 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

Interventions

  • 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

Primary Measures

  • – Pain management
    • Time Frame: 3 months
    • VAS scale

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Investigator Details

  • Lead Sponsor
    • Contipro Pharma a.s.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Pavel Ku┼ínierik, +420775 418 823, pavel.kusnierik@contipro.com

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