Study With Fascigel

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.

Completed

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicinecare s.r.o., Brno, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fascigel

Device

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

Primary outcomes

- Pain management

Time frame: 3 months

Visual Analogue Scale - 0-100 - higher scores mean a worse outcome

Sponsors and collaborators

Lead sponsor

Contipro Pharma a.s.

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 23, 2022
Registry last updated: Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed