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Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis (VMT-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841462
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Vesalius Medical Technologies

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.

Condition or disease Intervention/treatment Phase
Bursitis Device: Intra-bursal thermal ablation Not Applicable

Detailed Description:

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 course of the clinical trial.

As soon as a first AR is reported, the patient in whom the AR was reported will be considered as the first in a cohort of 3 patients treated at the same temperature and the remainder of the study will be conducted with cohorts of 3 patients treated in the same conditions.

Patients will be assessed at 6 different study visits: at baseline (Day 1), 1 day (24/72h) after treatment, 1 week after treatment (+/- 1 day), 3 weeks after treatment (+/- 2 days), 6 weeks (+/- 1 week) after treatment, and 6 months (+/- 2 weeks) after treatment. At any time during the 6-months study period an unscheduled visit may be performed. Patients will be requested to score weekly patient reported outcome assessments (PRO) until Week 6 and at Month 6, and to record any possible ARs and bursitis related treatments. At Week 2, Week 4 and Week 5 the patient will complete the PRO at home.

Assessments to be performed at every study visit include: physical examination (with focus on the bursitis), vital signs (including HR and temperature), PRO, adverse events (AE), concomitant medication(s) and treatment(s). An ultrasound exam of the bursa (according to standard ultrasound protocol) is to be performed at baseline and at week 6 (week 1 assessment is optional).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis

Arm Intervention/treatment
Experimental: Bursitis
Intra-bursal thermal ablation
Device: Intra-bursal thermal ablation
A single 3-minute intra-bursal perfusion of a physiological saline solution at increasing temperatures using the Ablaflex device.
Other Name: Ablaflex




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Other Outcome Measures:
  1. Bursa examination as assessed with Anamnesis and Physical examination [ Time Frame: week 1 ]
    A complete physical examination will be performed on each participant.

  2. Bursa examination as assessed with Anamnesis and Physical examination [ Time Frame: week 3 ]
    A complete physical examination will be performed on each participant.

  3. Bursa examination as assessed with Anamnesis and Physical examination [ Time Frame: week 6 ]
    A complete physical examination will be performed on each participant.

  4. Bursa examination as assessed with Anamnesis and Physical examination [ Time Frame: 6 months ]
    A complete physical examination will be performed on each participant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
  2. 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.
  3. Subject understands the investigational nature of the trial and is willing and able to comply with the trial requirements.
  4. Subject is aged ≥ 18 years.
  5. 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.

Exclusion Criteria:

  1. Subject is pregnant or nursing.
  2. 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.
  3. Subject has previously received corticoid drug treatment for his/her bursitis within 1 month from baseline.
  4. Subject suffers from non-bursitis related pain that may, according to the investigator, interfere with bursitis-related pain assessment.
  5. 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).
  6. 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.
  7. Subject suffers from insulin dependent diabetes or a clinically relevant blood clotting disorder.
  8. Subject receives immunotherapy, chemotherapy, immunodepressant treatment, or systemic corticosteroid treatment (locally administered corticosteroids, except in the bursitis region, and inhaled corticoid treatments are allowed).
  9. Subject is planning to move or travel in the next 6 months, which will interfere with or jeopardize the study follow-up schedule.
  10. Bursa volume estimated by ultrasound examination > 25 cc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841462


Contacts
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Contact: Stoffel Mulier +32477248888 stoffel.mulier@vesaliusmt.com

Locations
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Belgium
Vesalius Medical Technologies Recruiting
Hoegaarden, Belgium, 3320
Contact: Stoffel Mulier    +32477248888    stoffel.mulier@vesaliusmt.com   
Sponsors and Collaborators
Vesalius Medical Technologies
Investigators
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Principal Investigator: Bart Berghs, MD AZ Sint-Jan AV
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Responsible Party: Vesalius Medical Technologies
ClinicalTrials.gov Identifier: NCT02841462    
Other Study ID Numbers: VMT-001
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vesalius Medical Technologies:
thermal ablation
recurrent Bursitis
chronic Bursitis
olecranon
intra-bursal perfusion
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases