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Enrolling By Invitation
NCT05625984
Study With Fascigel
Conditions: Back Pain
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: Contipro Pharma a.s.
Location: Czechia
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.
Eligibility Criteria
Inclusion Criteria:Back pain (VAS above 4 cm)Limited range of motionDuration of pain for over 3 monthsPatient willing and able to provide the written consentAbility to communicate well with the investigator in the local language, and to understand and comply with the requirements of the studyExclusion Criteria:State after back surgeryBMI > 35Age < 18 yearsPregnant or lactating womanPatient in terminal stage of livingPatient with known hypersensitivity or allergy to any of substances contained in Medical DevicePatient participating in the intervention clinical studyAlcohol or drug abusePatient undergoing chronic coagulation therapy
Source: ClinicalTrials.gov (NCT05625984). StuddyBuddy aggregates publicly available trial information.
