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Study With Fascigel

Primary Purpose

Back Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Fascigel
Sponsored by
Contipro Pharma a.s.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medicinecare s.r.o.
  • FN Královské Vinohrady
  • FN Motol

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fascigel injection application

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
November 23, 2022
Sponsor
Contipro Pharma a.s.
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1. Study Identification

Unique Protocol Identification Number
NCT05625984
Brief Title
Study With Fascigel
Official Title
Multi-centre, Open-label, First-in-man Study With Fascigel Used in Adult Patients Suffered From Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contipro Pharma a.s.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fascigel injection application
Arm Type
Experimental
Arm Description
Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.
Intervention Type
Device
Intervention Name(s)
Fascigel
Intervention Description
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.
Primary Outcome Measure Information:
Title
- Pain management
Description
Visual Analogue Scale - 0-100 - higher scores mean a worse outcome
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medicinecare s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
FN Královské Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
FN Motol
City
Praha
ZIP/Postal Code
150 06
Country
Czechia

12. IPD Sharing Statement

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Study With Fascigel

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