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RECRUITING
NCT07336849
NA

Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment

Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

View on ClinicalTrials.gov

Summary

Evaluation of the efficacy and safety of transcatheter arterial embolization using 'Nexsphere-F' for pain relief in patients with adhesive capsulitis of the shoulder joint that does not respond to conservative treatment. This study aims to investigate the efficacy and safety of transcatheter arterial embolization using embolic agents in patients with adhesive capsulitis of the shoulder joint. This is a single-center, prospective, open-label, randomized clinical trial.

Official title: A Single-center, Prospective, Open Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Arterial Embolization Using 'Nexsphere-F' in Patients With Adhesive Capsulitis of the Shoulder Joint Refractory to Conservative Treatment.

Key Details

Gender

All

Age Range

19 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2025-09-18

Completion Date

2027-08-31

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

PROCEDURE

Transcatheter Arterial Micro- Embolization (TAME)

A one-time transcatheter arterial micro-embolization (TAME) procedure will be performed via radial artery access. After angiographic identification of abnormal neovascularity or hypervascular lesions associated with shoulder pain, target vessels will be superselected with a microcatheter and embolized using Nexsphere-F (gelatin-based bioresorbable embolic particles) until angiographic stasis or marked reduction of abnormal hyperemia is achieved, according to operator judgement.

OTHER

Usual care (conservative management)

Usual conservative management for shoulder pain provided as part of standard clinical care. Conservative treatments (e.g., physical therapy, analgesic medications, and/or intra-articular hyaluronic acid injection) may be provided based on clinical judgement and patient preference and are not mandated or standardized by the study protocol.

Locations (1)

Chung-Ang Univerisity Hospital

Seoul, South Korea