DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lum... | NCT03309371

Studies
DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc

NCT03309371

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Mar 14, 2018Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Hernia

Interventions

Not provided

Countries

France

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

Oct 2017

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

Jul 8, 2016Actual

Primary Completion Date

Aug 31, 2016Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Oct 9, 2017

First Submission Date that Met QC Criteria

Oct 12, 2017

First Posted Date

Oct 13, 2017Actual

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

Mar 12, 2018

Last Update Posted Date

Mar 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Lumbar disc herniation is the most important and frequent affection in rheumatology. The first treatment is based on an non-steroidal anti-inflammatory drugs.Physiotherapy also is used.But when there is no efficient result, it's usual to propose to the patient corticoid injection, percutaneous intervention or arthrodesis.

Recently DISCOGEL® is a medical device used for lumbar disc herniation. However there is no studies evaluating the benefit and the efficiency of this technic. Since a few years, the rheumatology service of GHPSJ practise this technic using DISCOGEL® with patient resistant to the medical treatment . So the aim is to evaluate the benefit of DISCOGEL® retrospectively.

Detailed Description

Not provided

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

27Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years		Baseline, 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age> 18
lumbar radiculalgy
lumbar disc herniation described by MRI
more than 6 weeks
prescription of DISCOGEL

Exclusion Criteria:

medical history of surgery at the same stage
patient under Clopidogrel or prasugrel

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

every patient with a DISCOGEL treatment between January 2014 and may of 2016

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided