Study With Fascigel | NCT05625984

Studies
Study With Fascigel

NCT05625984

Sponsor

Contipro Pharma a.s.

Status

Completed

Last Update Posted

Feb 7, 2024Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Back Pain

Interventions

Fascigel

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2022Actual

Primary Completion Date

Nov 13, 2023Actual

Completion Date

Nov 13, 2023Actual

First Submitted Date

Nov 15, 2022

First Submission Date that Met QC Criteria

Nov 15, 2022

First Posted Date

Nov 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fascigel injection application	Experimental	Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.	Device: Fascigel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fascigel	Device	The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.	Fascigel injection application

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Pain management	Visual Analogue Scale - 0-100 - higher scores mean a worse outcome	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicinecare s.r.o.		Brno		602 00	Czechia
FN Královské Vinohrady

Condition Browse Module

MeSH Terms

ID	Term
D001416	Back Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided