BursitisVMT-001NCT02841462
Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis
A study testing Intra-bursal thermal ablation in people with Bursitis, run by Vesalius Medical Technologies at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bursitis
- What is being tested?
- Intra-bursal thermal ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2016to 22 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Bursitis
- Being tested
- Intra-bursal thermal ablation
- Keywords
- thermal ablation, recurrent Bursitis, chronic Bursitis, olecranon, intra-bursal perfusion
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-bursal thermal ablationDevice
Also called Ablaflex
A single 3-minute intra-bursal perfusion of a physiological saline solution at increasing temperatures using the Ablaflex device.
| Study group | Role | What they receive |
|---|---|---|
| Bursitis | Experimental | Intra-bursal thermal ablation Receives: Device: Intra-bursal thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to week 6
Secondary outcomes (12)
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
Measured: From Baseline to Week 6
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
Measured: From Baseline to Month 6
Patient treatment satisfaction as assessed with Patient Global Impression (PGI)
Patient Global Impression (PGI) form assesses change from baseline at 6 weeks after treatment
Measured: From Baseline to Week 6
Patient treatment satisfaction as assessed with Patient Global Impression (PGI)
Patient Global Impression (PGI) form assesses change from baseline at 6 months after treatment
Measured: From Baseline to Month 6
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
Measured: Week 1
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
Measured: Week 3
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
Measured: Week 6
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
Measured: Month 6
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.
Measured: From Baseline to day 1
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.
Measured: From Baseline to Week 2
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.
Measured: From Baseline to Week 3
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.
Measured: From Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start1 May 2016
- Primary completionDec 2022
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BursitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vesalius Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Berghs, MD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841462
- Sponsor's protocol ID
- VMT-001
- Acronym
- VMT-001
- Status last verified
- Apr 2023
- First submitted
- 10 Jun 2016
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02841462
- Acronym / sponsor ID
- VMT-001 / VMT-001
- Conditions
- Bursitis
- Keywords
- thermal ablation, recurrent Bursitis, chronic Bursitis, olecranon, intra-bursal perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vesalius Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 May 2016
- Primary completion
- Dec 2022 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bursitis | Experimental | Device: Intra-bursal thermal ablationIntra-bursal thermal ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-bursal thermal ablationAlso: AblaflexA single 3-minute intra-bursal perfusion of a physiological saline solution at increasing temperatures using the Ablaflex device. | Device | Bursitis |
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.
12 secondary outcomes
Bursa volume as assessed with ultrasound examination
Time frame: From Baseline to Week 6
Bursa volume as assessed with ultrasound examination
Time frame: From Baseline to Month 6
Patient treatment satisfaction as assessed with Patient Global Impression (PGI)
Time frame: From Baseline to Week 6
Patient treatment satisfaction as assessed with Patient Global Impression (PGI)
Time frame: From Baseline to Month 6
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Time frame: Week 1
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Time frame: Week 3
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Time frame: Week 6
Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index
Time frame: Month 6
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Time frame: From Baseline to day 1
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Time frame: From Baseline to Week 2
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Time frame: From Baseline to Week 3
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
Time frame: From Baseline to Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Berghs, MD principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-bursal thermal ablation in people with Bursitis, run by Vesalius Medical Technologies at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bursitis related disability as assessed on Patient Reported Outcome (PRO) (time frame: From Baseline to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.