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Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

NCT03676829 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-09-21

No results posted yet for this study

Summary

This study is to test a new treatment method, arterial embolization of the shoulder (AES), to reduce the severity of pain and improve range of motion (ROM), and to see if it can be performed safely.

Conditions

  • Frozen Shoulder
  • Adhesive Capsulitis

Interventions

DEVICE

Arterial Embolization of the Shoulder

Arterial Embolization of the Shoulder (AES) is a new procedure that is being used to reduce pain and improve range of motion (ROM) caused by adhesive capsulitis. Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the shoulder, resulting in improvement of pain, stiffness and from adhesive capsulitis.

Sponsors & Collaborators

  • Terumo Medical Corporation

    collaborator INDUSTRY

  • Vascular Institute of Virginia

    lead OTHER

Principal Investigators

  • Sandeep Bagla, MD · Vascular Institute of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2019-08-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03676829 on ClinicalTrials.gov