Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis (VMT-001)
Primary Purpose
Bursitis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Intra-bursal thermal ablation
Sponsored by
About this trial
This is an interventional treatment trial for Bursitis focused on measuring thermal ablation, recurrent Bursitis, chronic Bursitis, olecranon, intra-bursal perfusion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Vesalius Medical Technologies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bursitis
Arm Description
Intra-bursal thermal ablation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Bursa volume as assessed with ultrasound examination
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
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)
Patient Global Impression (PGI) form assesses change from baseline at 6 weeks after treatment
Patient treatment satisfaction as assessed with Patient Global Impression (PGI)
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
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
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
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
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)
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)
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)
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)
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.
Full Information
NCT ID
NCT02841462
First Posted
June 10, 2016
Last Updated
April 27, 2023
Sponsor
Vesalius Medical Technologies
1. Study Identification
Unique Protocol Identification Number
NCT02841462
Brief Title
Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis
Acronym
VMT-001
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 Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
February 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vesalius Medical Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bursitis
Keywords
thermal ablation, recurrent Bursitis, chronic Bursitis, olecranon, intra-bursal perfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bursitis
Arm Type
Experimental
Arm Description
Intra-bursal thermal ablation
Intervention Type
Device
Intervention Name(s)
Intra-bursal thermal ablation
Other Intervention Name(s)
Ablaflex
Intervention Description
A single 3-minute intra-bursal perfusion of a physiological saline solution at increasing temperatures using the Ablaflex device.
Primary Outcome Measure Information:
Title
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Description
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.
Time Frame
From Baseline to week 6
Secondary Outcome Measure Information:
Title
Bursa volume as assessed with ultrasound examination
Description
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
Time Frame
From Baseline to Week 6
Title
Bursa volume as assessed with ultrasound examination
Description
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
Time Frame
From Baseline to Month 6
Title
Patient treatment satisfaction as assessed with Patient Global Impression (PGI)
Description
Patient Global Impression (PGI) form assesses change from baseline at 6 weeks after treatment
Time Frame
From Baseline to Week 6
Title
Patient treatment satisfaction as assessed with Patient Global Impression (PGI)
Description
Patient Global Impression (PGI) form assesses change from baseline at 6 months after treatment
Time Frame
From Baseline to Month 6
Title
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Description
Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
Time Frame
Week 1
Title
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Description
Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
Time Frame
Week 3
Title
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Description
Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
Time Frame
Week 6
Title
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Description
Clinical Global Impression (CGI) Efficacy Index assesses, for each treatment, the perceived safety and efficacy of the study treatment administered (investigator) after treatment
Time Frame
Month 6
Title
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Description
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.
Time Frame
From Baseline to day 1
Title
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Description
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.
Time Frame
From Baseline to Week 2
Title
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Description
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.
Time Frame
From Baseline to Week 3
Title
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Description
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.
Time Frame
From Baseline to Month 6
Other Pre-specified Outcome Measures:
Title
Bursa examination as assessed with Anamnesis and Physical examination
Description
A complete physical examination will be performed on each participant.
Time Frame
week 1
Title
Bursa examination as assessed with Anamnesis and Physical examination
Description
A complete physical examination will be performed on each participant.
Time Frame
week 3
Title
Bursa examination as assessed with Anamnesis and Physical examination
Description
A complete physical examination will be performed on each participant.
Time Frame
week 6
Title
Bursa examination as assessed with Anamnesis and Physical examination
Description
A complete physical examination will be performed on each participant.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Berghs, MD
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vesalius Medical Technologies
City
Hoegaarden
ZIP/Postal Code
3320
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis
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