EuroPainClinics® Study III (Prospective Observational Study) | NCT02461654

Studies
EuroPainClinics® Study III (Prospective Observational Study)

NCT02461654

Sponsor

EPC Education s.r.o.

Status

Terminated

Last Update Posted

Jan 13, 2022Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Disc Herniations

Interventions

Disc FX

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The clinical trial was suspended for the reason that preliminary results in 20 patients didn't show a significant curative effect of observed treatment.

Expanded Access Info

Start Date

Dec 31, 2018Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

May 26, 2015

First Submission Date that Met QC Criteria

May 31, 2015

First Posted Date

Jun 3, 2015Estimated

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

Dec 30, 2021

Last Update Posted Date

Jan 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In this prospective observational trial the effect of the Disc FX microinvasive therapy should be examined in (approximately 150) adult patients with low back pain.

Detailed Description

Patients will be selected from 4 participating clinics from Czech and Slovak republic. Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

Back pain due to Lumbar Disc Disease in our population is a very common problem. The treatment options range from physiotherapy to fusion surgery. When all conservative treatment is failed than in some cases with suitable conditions of intervertebral disc is possible to avoid classical disc surgery with minimally invasive surgery techniques. A number of minimally invasive procedures have also been developed in the recent past for its management. One of them is Disc FX procedure. Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. This method provides an option for those people who have not benefited from conservative treatment, and are not yet ready for major surgery. It is a minimal-access procedure performed on an out-patient basis. Its big advantage is the fact that the patient may go home the same day. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.

Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Disc FX	Other	Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain as assessed by the Visual analogue scale	All acquired information will be noted in to the special anonymous protocol	3 years

Secondary Outcomes

Measure	Description	Time Frame
Pain localization as assessed by note of radiating dermatome as neurologic examination	All acquired information will be noted in to the special anonymous protocol	3 years
Pain progress as assessed by global pain scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who undergo Disc FX therapy

Exclusion Criteria:

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juraj Mláka, MD PhD	R-Clinic	Study Chair
Ladislav Kočan, MD PhD	K-medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algesiology ambulance		Prague			Czechia

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided