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

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

Sponsors

Lead Sponsor: Contipro Pharma a.s.

Source Contipro Pharma a.s.
Brief Summary

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.

Overall Status Recruiting
Start Date 2022-10-19
Completion Date 2023-12-31
Primary Completion Date 2023-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
- Pain management 3 months
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: Fascigel

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

Arm Group Label: Fascigel injection application

Eligibility

Criteria:

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:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Pavel Kušnierik

Phone: +420775 418 823

Email: [email protected]

Location
Facility: Status: Contact:
Medicinecare s.r.o. | Brno, 602 00, Czechia Recruiting Marek Hakl, Ph.D. +420603260888 [email protected]
FN Královské Vinohrady | Praha, 100 34, Czechia Not yet recruiting Šimon Kozák, M.D. +420739683636 [email protected]
FN Motol | Praha, 150 06, Czechia Recruiting Jiří Kozák, Ph.D. +420224435580 [email protected]
Location Countries

Czechia

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Fascigel injection application

Type: Experimental

Description: Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Back Pain

Clinical Trials on Fascigel