Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis With the Ablaflex Device: An Open, Exploratory, 6-month Dose-tolerance and Dose Response Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Bursitis related disability as assessed on Patient Reported Outcome (PRO)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Bursitis related disability as assessed on Patient Reported Outcome (PRO)
时间窗: 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.
次要结局
- Physician treatment satisfaction as assessed with Clinical Global Impression (CGI) Efficacy Index(Month 6)
- Patient treatment satisfaction as assessed with Patient Global Impression (PGI)(From Baseline to Month 6)
- Bursa volume as assessed with ultrasound examination(From Baseline to Month 6)
- Bursitis related disability as assessed on Patient Reported Outcome (PRO)(From Baseline to Month 6)