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Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis

NCT02841462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-05-01

No results posted yet for this study

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

Interventions

DEVICE

Intra-bursal thermal ablation

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

Sponsors & Collaborators

  • Vesalius Medical Technologies

    lead INDUSTRY

Principal Investigators

  • Bart Berghs, MD · AZ Sint-Jan AV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2022-12-31
Completion
2023-02-22

Countries

  • Belgium

Study Locations

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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 NCT02841462 on ClinicalTrials.gov