Clinical Trial: Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis With the Ablaflex Device: An Open, Exploratory, 6-month Dose-tolerance and Dose Response Study

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.

Detailed Summary:

This is an open, exploratory, 6-months dose-tolerance and dose-response study of a single thermal ablation (Ablaflex) procedure in subjects suffering from chronic symptomatic bursitis.

Possible study participants will be screened for eligibility based on defined inclusion and exclusion criteria.

Eligible patients will be administered with a single 3-minute perfusion of a physiological saline solution at a specific temperature between 50° Celsius and 55° Celsius. If the volume of the bursa estimated by ultrasound examination is ≤ 10 cc, the perfusion will be performed at a rate of 3mL/second. If the volume of the bursa is > 10 cc and ≤ 25 cc, the perfusion will be performed at a rate of 4mL/second. If the volume of the bursa is > 25 cc, the subject is considered as screen failure (exclusion criterion # 10). Immediately prior to and immediately after the thermal ablation phase of 3 minutes, perfusion with a physiological saline solution at room temperature (22°C) will be performed during 2 minutes. In total the bursa will be rinsed during 7 minutes. An elastic bandage (Elastoplast) will be applied immediately after the procedure to compress the bursa cavity. It should be worn for 6 weeks.

The first patient with bursitis of olecranon will be administered physiological saline solution at a temperature of 50° Celsius, and subsequent patients will receive perfusions with increments of 0.5 to 1° Celsius as long as no AR (of any intensity) is reported.

As long as no AR is reported, but when a first CR or PR is reported for a specific temperature, the patient in whom CR or PR was reported will be considered as the first in a cohort of 3 patients treated at the same temperature during the cou
Sponsor: Vesalius Medical Technologies

Current Primary Outcome: Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: From Baseline to week 6 ]

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.


Original Primary Outcome: Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: week 6 ]

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.


Current Secondary Outcome:

  • Bursa volume as assessed with ultrasound examination [ Time Frame: From Baseline to Week 6 ]
    Ultrasound examination assesses response to treatment by measuring change of bursa volume at week 6 compared to baseline, resulting in either Complete Response (CR), Partial Response (PR), Minor Response (MR) No Response (NR) as defined in the protocol
  • Bursa volume as assessed with ultrasound examination [ Time Frame: From Baseline to Month 6 ]
    Ultrasound examination assesses response to treatment by measuring change of bursa volume at month 6 compared to baseline, resulting in either Complete Response (CR), Partial Response (PR), Minor Response (MR) No Response (NR) as defined in the protocol
  • Patient treatment satisfaction as assessed with Patient Global Impression (PGI) [ Time Frame: From Baseline to Week 6 ]
    Patient Global Impression (PGI) form assesses change from baseline at 6 weeks after treatment
  • Patient treatment satisfaction as assessed with Patient Global Impression (PGI) [ Time Frame: From Baseline to Month 6 ]
    Patient Global Impression (PGI) form assesses change from baseline at 6 months after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Week 1 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Week 3 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Week 6 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Month 6 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: From Baseline to day 1 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on day 1. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: From Baseline to Week 2 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on week 2. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: From Baseline to Week 3 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on Week 3. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: From Baseline to Month 6 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on month 6. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.


Original Secondary Outcome:

  • Bursa volume as assessed with ultrasound examination [ Time Frame: Week 6 ]
    Ultrasound examination assesses response to treatment by measuring change of bursa volume at week 6 compared to baseline, resulting in either Complete Response (CR), Partial Response (PR), Minor Response (MR) No Response (NR) as defined in the protocol
  • Bursa volume as assessed with ultrasound examination [ Time Frame: Month 6 ]
    Ultrasound examination assesses response to treatment by measuring change of bursa volume at month 6 compared to baseline, resulting in either Complete Response (CR), Partial Response (PR), Minor Response (MR) No Response (NR) as defined in the protocol
  • Patient treatment satisfaction as assessed with Patient Global Impression (PGI) [ Time Frame: Week 6 ]
    Patient Global Impression (PGI) form assesses change from baseline at 6 weeks after treatment
  • Patient treatment satisfaction as assessed with Patient Global Impression (PGI) [ Time Frame: Month 6 ]
    Patient Global Impression (PGI) form assesses change from baseline at 6 months after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Week 1 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Week 3 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Week 6 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index [ Time Frame: Month 6 ]
    Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: day 1 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on day 1. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: Week 2 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on week 2. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: Week 3 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on Week 3. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.
  • Bursitis related disability as assessed on Patient Reported Outcome (PRO) [ Time Frame: Month 6 ]
    Patient Reported Outcome (PRO) form assesses change from baseline on month 6. The PRO form will consist of the DASH (DASH: Disabilities of the Arm, Shoulder and Hand) for olecranon bursitis.


Information By: Vesalius Medical Technologies

Dates:
Date Received: June 10, 2016
Date Started: May 2016
Date Completion: April 2017
Last Updated: July 27, 2016
Last Verified: July 2016