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NCT05625984 Clinical Trial

Study With Fascigel

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05625984
Other study ID # PT-FAS-1_11-21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2022
Est. completion date November 13, 2023

Study information
Verified date February 2024
Source Contipro Pharma a.s.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. The device intended use is to help treat back pain by lubricating fascia.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date November 13, 2023
Est. primary completion date November 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Fascigel
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.

Locations
Country Name City State
Czechia Medicinecare s.r.o. Brno
Czechia FN Královské Vinohrady Praha
Czechia FN Motol Praha

Sponsors (1)
Lead Sponsor Collaborator
Contipro Pharma a.s.

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary - Pain management Visual Analogue Scale - 0-100 - higher scores mean a worse outcome 3 months
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