This is an open, exploratory, 6-months dose-tolerance and dose-response study of a single thermal ablation procedure in subjects suffering from chronic symptomatic bursitis.
Thermal ablation is a technique of destroying (dysfunctional) cells using heat. Thermal ablation has been used successfully to treat heart arrhythmias, benign prostate hyperplasia, and non-operable tumors (Habash et al. 2007), as well as menorrhagia (Lavazzo et al., 2008), emphysema (Gompelmann et al., 2012) and varicose veins (Djalali et al., 2012). More specifically, in the treatment of menorrhagia (excessive menstrual bleeding), hydrothermal ablation of the endometrium (using heated water) aims at stopping excessive bleeding by removing the internal uterine glandular layer and was found to be effective, safe and cost-efficient (Health Quality Ontario, 2004).
ABLAflex™ is a medical device that applies a perfusion of heated physiological saline solution to the inflamed bursa with the objective to obtain a necrotizing effect on the inner synovial layer of the bursa. ABLAflex™ is currently under clinical investigation and is not commercially available. Cell death is reported to occur during exposure to temperatures ranging from 50 to 55° Celsius for a period up to 3 minutes (Heisterkamp et al., 1999). The synovial lining is eventually replaced by scar tissue, along with the elimination of excessive fluid and inflammation resulting in pain relief. Hydrothermal ablation with ABLAflex™ is a minimally invasive procedure.
ABLAflex™ applies a perfusion of the Bursa with a heated saline solution. The rinsing with fluid exists out of several phases whereby the total duration is less than 10 minutes.
3 minutes heated perfusion
Fast and simple minimally invasive procedure
No medication, no pharmaceuticals,
Fast pain relief
Ambulatory one day treatment
No side effects
Reduced infection risks compared to surgery
No plaster cast (or immobilization) compared to surgery
No wound healing problems compared to surgery
No (painful) revalidation compared to surgery
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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.
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
The technology and methodology is covered by Patent Nos. 0287764, 2528636, 5827241, 279232,... Other patents may be pending.
Clinical trial (NCT02841462): Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis (VMT-001)
Bursitis is defined as an inflammation of a bursa, which is a common cause of pain and discomfort and often prompts for orthopedic consultation. A bursa is a saclike structure between skin and bone or between tendons, ligaments, and bone. A bursa is lined by synovial tissue, which produces fluid that lubricates and reduces friction between these structures. Bursitis occurs when the synovial lining becomes thickened and produces excessive fluid, leading to localized swelling and pain (Sheon et al., 1996; Crenshaw & Canale, 1998; DeLee & Drez, 2003; Fathy & Radad 2006). Most common types of bursitis are the trochanteric, olecranon, peripatellar and shoulder bursitis.
Healthy bursae create a smooth, almost frictionless functional gliding surface making normal movement painless. When bursitis occurs, however, movement relying upon the inflamed bursa becomes difficult and painful.
Bursitis is a common disorder: the incidence of trochanteric bursitis is estimated to be 1.8/1000/year. Prevalence for people between 50 and 80: unilateral trochanteric bursitis is present in approximately 15% of women and 8.5% of men; bilateral trochanteric bursitis is present in up to 6.6% of women and 1.9% of men (Foye). Bursitis is the cause of 0.4% of all primary care physician visits, and is present in up to 10% of individuals who are runners (Gonsalves). After hip osteoarthritis, trochanteric bursitis is the second most common cause of adult hip pain (Foley).
Bursitis can very reliably be diagnosed and described using ultrasound techniques (Blankstein et al., 2006; Fearon et al., 2010; Westacott et al., 2011).
Most patients with non-septic bursitis respond to nonsurgical management, including ice, activity modification, and non-steroidal anti-inflammatory drugs. Aspiration or surgical drainage of fluid from the bursa is an alternative treatment. Local corticosteroid injection has proven to be effective in the management of bursitis (corticosteroids must be dosed carefully because of the long list of potential side-effects) and surgical intervention may be required for recalcitrant bursitis, such as refractory trochanteric bursitis (Schapira et al., 1986; Aaron et al., 2011), as pain can be severe and disabling (Lievense et al., 2005; Baker et al., 2007).
However, recurrence of bursitis complaints after corticosteroid injection is reported to be common (Rasmussen & Fana, 1985; Bard 2002, Sayegh et al., 2004), while surgical resection, which is reserved as a last resort, is not devoid of recurrence nor complications (Stewart et al., 1997; Degreef & De Smet, 2006).