NCT06872567

Brief Summary

Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

February 27, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

February 27, 2025

Last Update Submit

November 19, 2025

Conditions

Knee Osteoarthritis (Knee OA)

Outcome Measures

Primary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living.

    6 and 12-month post treatment

  • Serious Adverse Events (SAE)

    Treatment, 1,3,6,9 and 12-month post treatment

Secondary Outcomes (1)

  • WOMAC total score

    9 month post treatment

Study Arms (2)

Control

ACTIVE COMPARATOR
Drug: Corticosteroid Injection

Device: GAE

EXPERIMENTAL
Device: genicular artery embolization

Interventions

genicular artery embolizationDEVICE

genicular artery embolization

Device: GAE
Corticosteroid InjectionDRUG

Corticosteroid Injection

Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has localized knee pain
  • Must be an appropriate candidate for arterial vascular access procedure

You may not qualify if:

  • Known sensitivity or allergy to implant materials
  • Unable or unwilling to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Ziv J Haskal, MD

CONTACT

16463691570haskalembo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 12, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations

US(1)