Clinical Trials Logo
  1. Home
  2. Hernia
  3. NCT03309371
  4. Details
NCT03309371 Clinical Trial

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

Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03309371
Other study ID # DISCOGEL
Secondary ID
Status Completed
Phase N/A
First received October 9, 2017
Last updated March 12, 2018
Start date July 8, 2016
Est. completion date December 31, 2017

Study information
Verified date October 2017
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date December 31, 2017
Est. primary completion date August 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years Baseline, 2 years
See also
  Status Clinical Trial Phase
Completed NCT01629485 - Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair N/A
Completed NCT01205399 - A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft N/A
Terminated NCT01305486 - A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation N/A
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00905320 - Hernia Repair With or Without Sutures N/A
Completed NCT00617357 - Repair of Infected or Contaminated Hernias N/A
Completed NCT00535990 - Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Withdrawn NCT00138957 - Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh N/A
Completed NCT06034652 - T-GENVIH-003 LTFU (Long Term Follow Up) Study
Completed NCT06389331 - Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia
Completed NCT04119466 - Stabilizing Training in Degenerative Disc Disease N/A
Completed NCT00622583 - International Hernia Mesh Registry
Completed NCT04137172 - Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia. N/A
Completed NCT01132209 - Suture Techniques to Reduce the Incidence of The inCisional Hernia N/A
Completed NCT00032448 - Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients? Phase 3
Not yet recruiting NCT05061589 - Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China
Active, not recruiting NCT02439060 - PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit) N/A
Completed NCT02238964 - Reinforcement of Closure of Stoma Site Phase 2/Phase 3
Completed NCT01727388 - Informativeness to Digital Rectal Examination Phase 3
Completed NCT01997619 - Biological Mesh Repair of Complex Hernias in High Risk Patients N/A