Other Clinical Trial - The MiDAS ENCORE Study

Clinical Trial Summary

Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Constriction, Pathologic
Intermittent Claudication
Spinal Stenosis
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

See also
Status	Clinical Trial	Phase
Completed	`NCT03863067` - Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis	N/A
Terminated	`NCT01995461` - Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis	N/A
Active, not recruiting	`NCT03610737` - The MOTION Study - Treatment of LSS With the MILD Procedure	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT03863067 - Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis

N/A

Terminated

NCT01995461 - Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis

N/A

Active, not recruiting

NCT03610737 - The MOTION Study - Treatment of LSS With the MILD Procedure

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02093520
Study type	Interventional
Source	Vertos Medical, Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 2014
Completion date	October 2017