Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477965
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Embo Registry National Registry for Artery Embolization
Sponsor:
Vascular Solutions of North Carolina
Organization:
Vascular Solutions of North Carolina
Study Overview
Official Title:
Multicenter National Registry for Artery Embolization Embo Registry for the Treatment of Osteoarthritis and Areas of Localized Pain to Assess Treatment of Artery Embolization to Determine if Subjects Have Decrease Pain Decreased Use of Narcotics and NSAIDs and Quality of Life Improvement Post Procedure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life
Detailed Description:
Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes The embolic solution is used during an outpatient procedure the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain Tiny particles are then injected through the catheter into these arteries reducing blood flow to the target area This reduces the amount of inflammation associated with osteoarthritis tendonitis tenosynovitis or an injury a process that can help decrease symptoms or eliminate the associated localized pain to this area With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment For the study to determine efficacy and overall improvement of patients post procedure by comparing patients pain preoperative and post operatively if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale VAS scores Western Ontario and McMaster Universities Index WOMAC EQ-5D-5L Quality of Life Questionnaire and to determine if patients had decrease used of medication prescribed preoperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None