NCT05625984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

November 15, 2022

Last Update Submit

February 6, 2024

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

  • - Pain management

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

    3 months

Study Arms (1)

Fascigel injection application

EXPERIMENTAL

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

Device: Fascigel

Interventions

FascigelDEVICE

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

Fascigel injection application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medicinecare s.r.o.

Brno, 602 00, Czechia

Location

FN Královské Vinohrady

Prague, 100 34, Czechia

Location

FN Motol

Prague, 150 06, Czechia

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

October 24, 2022

Primary Completion

November 13, 2023

Study Completion

November 13, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

CZ(3)