Study With Fascigel

Sponsor

Contipro Pharma a.s. (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05625984

Collaborator

(none)

Enrollment

Locations

Arm

14.4

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain	Device: Fascigel	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 19, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fascigel injection application Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.	Device: Fascigel The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.

Arm

Intervention/Treatment

Experimental: Fascigel injection application

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

Device: Fascigel

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

Outcome Measures

Primary Outcome Measures

- Pain management [3 months]
Visual Analogue Scale - 0-100 - higher scores mean a worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Medicinecare s.r.o.	Brno	Czechia	602 00
2	FN Královské Vinohrady	Praha	Czechia	100 34
3	FN Motol	Praha	Czechia	150 06

Sponsors and Collaborators

Contipro Pharma a.s.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Contipro Pharma a.s.

ClinicalTrials.gov Identifier:

NCT05625984

Other Study ID Numbers:

PT-FAS-1_11-21

First Posted:

Nov 23, 2022

Last Update Posted:

Nov 29, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Study Results

No Results Posted as of Nov 29, 2022