Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis

NCT02841462 | Completed

• 1 other identifier: VMT-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this trial is to explore the dose-tolerance (safety) and dose-response (efficacy) of single 3-minute intra-bursal perfusions of a physiological saline solution at increasing temperatures.

Conditions

Bursitis

Keywords

thermal ablation; recurrent Bursitis; chronic Bursitis; olecranon; intra-bursal perfusion

Outcome Measures

Primary Outcomes (1)

• Bursitis related disability as assessed on Patient Reported Outcome (PRO)

  Patient Reported Outcome (PRO) form assesses change from baseline on week 6. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.

  From Baseline to week 6

Secondary Outcomes (12)

• Bursa volume as assessed with ultrasound examination

  From Baseline to Week 6

• Bursa volume as assessed with ultrasound examination

  From Baseline to Month 6

• Patient treatment satisfaction as assessed with Patient Global Impression (PGI)

  From Baseline to Week 6

• Patient treatment satisfaction as assessed with Patient Global Impression (PGI)

  From Baseline to Month 6

• Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index

  Week 1

Other Outcomes (4)

• Bursa examination as assessed with Anamnesis and Physical examination

  week 1

• Bursa examination as assessed with Anamnesis and Physical examination

  week 3

• Bursa examination as assessed with Anamnesis and Physical examination

  week 6

Study Arms (1)

Bursitis

EXPERIMENTAL

Intra-bursal thermal ablation

Device: Intra-bursal thermal ablation

Interventions

Intra-bursal thermal ablation DEVICE

A single 3-minute intra-bursal perfusion of a physiological saline solution at increasing temperatures using the Ablaflex device.

Also known as: Ablaflex

Bursitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
• Subject is fluent in Dutch and is able to read and understand study documents, such as the informed consent form, patient reported outcomes and diaries.
• Subject understands the investigational nature of the trial and is willing and able to comply with the trial requirements.
• Subject is aged ≥ 18 years.
• Subject is suffering from a recurrent bursitis of the olecranon, trochanter, prepatellar or infrapatellar region, confirmed by ultrasound examination (with image), or from a chronic (\>6 weeks) first episode bursitis of these regions.

You may not qualify if:

• Subject is pregnant or nursing.
• Subject has fever (\>37.5°C), a septic bursitis (confirmed by suppurative aspirate or positive bacteriagram), or an infection or inflammation (other than bursitis related) of the associated joint.
• Subject has previously received corticoid drug treatment for his/her bursitis within 1 month from baseline.
• Subject suffers from non-bursitis related pain that may, according to the investigator, interfere with bursitis-related pain assessment.
• Subject may not, according to the investigator, be able to participate or comply reliably with study procedure requirements (due to e.g. any psychiatric disorder).
• Subject suffers from a dermatological or other disease that may interfere with the study, its procedures and the study treatment administration (use of needles) or anesthetic procedures.
• Subject suffers from insulin dependent diabetes or a clinically relevant blood clotting disorder.
• Subject receives immunotherapy, chemotherapy, immunodepressant treatment, or systemic corticosteroid treatment (locally administered corticosteroids, except in the bursitis region, and inhaled corticoid treatments are allowed).
• Subject is planning to move or travel in the next 6 months, which will interfere with or jeopardize the study follow-up schedule.
• Bursa volume estimated by ultrasound examination \> 25 cc.

Sponsors & Collaborators

• Vesalius Medical Technologies: lead

Study Sites (1)

Vesalius Medical Technologies

Hoegaarden, 3320, Belgium

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Bart Berghs, MD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: July 22, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: February 22, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)