Oxford University Hospitals NHS Trust — Biomedical Watch V2

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Traitements

7

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Botulinum toxinSpasticity is an umbrella term for impairments of muscle tone and control in people with damage to the brain and spinal cord. It is highly prevalent and results in pain, stiffness, and contribute to difficulties in activities of daily living. Current treatment options are limited, and many people experience only partial reduction in spasticity and frequent repeated treatments are needed. Cryoneurolysis is a medical technique which involves the controlled freezing of the nerves. It has been approved in the UK for the treatment of pain in the context of spasticity through the targeting of nerves which control problematic muscles. Oxford University Hospitals NHS Foundation Trust has been offering this treatment routinely since January 2024. This pilot study aims to improve the understanding of the potential effectiveness of this treatment and its potential side effects when compared with a more commonly used treatment (Botulinum Toxin). Participants will be randomly allocated to receive usual care with Botulinum Toxin (control group) or usual care with Cryoneurolysis (intervention group). The investigators will assess pain, goal attainment, side effects, spasticity, disability and independence in daily activities, and movement of the arm and leg. Assessments will be at baseline and then 6-, 12-, 18-, and 24-weeks following treatment. Participants who are randomised to the control group will have the opportunity to receive cryoneurolysis treatment after the 12 week follow up assessment. The results of this study will help to guide future studies to examine the effectiveness of this treatment.	SEP	Phase 4	Traitement symptomatique	United Kingdom	À vérifier
CryoneurolysisThe trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine. Chronic migraine is a condition that causes moderate to severe headache. In this study, the investigators want to evaluate the freezing technique in chronic migraine. The main goal is to see how much headache relief is experienced after receiving the treatment. The investigators will also record other important information about the participants. The study is looking to recruit 12 adults with chronic migraine to take part in the study. Participants will register their headache burden in a headache diary for at least 4 weeks before receiving treatment with the freezing technique. They will continue to register headache in the headache diary during the follow-up. After this initial treatment, participants with recurring headache can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique may be viable treatment option for chronic migraine and enable us plan for further studies on this treatment.	Cancer, Migraine, SEP	Phase 4	Traitement symptomatique	United Kingdom	À vérifier
Pleural embolisationThermal ablation is an established treatment for lung cancer. It involves insertion of a applicator under image guidance into a lung tumour and destroying it with radiofrequency, microwave or cryotherapy. One of the common side effects is pneumothorax, which is a leak of gas from the lungs when it punctured. Air leak necessitates placement of a drainage tube in more than half of patients undergoing the procedure. The drain can be associated with some morbidity including pain, reduced mobility, prolonged hospital stay and infection Pleural embolization refers to the injection of substances to the linings of the lung to seal air leakage. There is published evidence in using pleural embolization with autologous blood (blood drawn up from the patient's veins) to prevent pneumothorax in patients undergoing lung biopsies. This technique is also known as pleural blood patch (PBP). A study involving more than 4000 patients found that PBP reduced the rates of pneumothorax by 35% and drain placement by 55% in lung patients. A study using prophylactic gelfoam torpedo embolization for radiofrequency ablation showed significant reduction in chest drain rates. In this study, investigators plan to evaluate the PBP using a tandem needle technique in patients undergoing lung ablation at the Oxford Thermal Ablation Service, one of the largest units in the country performing about 200 ablations per year, mostly microwave ablations. Patients will be randomized to receive lung ablation with or without the PBP. The PBP technique is easy to learn, enjoys high technical success rates and does not expose the patient to any significant additional risk. The primary outcome is the chest drains rates in the two trial groups: 1. patients undergoing lung ablation without PBP and 2. patients undergoing lung ablation with PBP. Other outcomes that would be measured include the volume of gas leakage on Computed Tomography (CT) imaging, safety profile, length of stay, feasibility of same day discharge, patient oriented outcomes including validated pain score, and institution oriented outcomes including medical costs. A positive trial could significantly reduce the side effect profile of lung ablation and hasten the patient's recovery. There could be significant savings in healthcare costs as the procedure may become safe to perform as a day procedure as opposed to an overnight procedure.	Cancer	Non applicable	Traitement symptomatique	United Kingdom	À vérifier
CryoneurolysisThe trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine. Chronic migraine is a condition that causes moderate to severe headache. In this study, the investigators want to evaluate the freezing technique in chronic migraine. The main goal is to see how much headache relief is experienced after receiving the treatment. The investigators will also record other important information about the participants. The study is looking to recruit 12 adults with chronic migraine to take part in the study. Participants will register their headache burden in a headache diary for at least 4 weeks before receiving treatment with the freezing technique. They will continue to register headache in the headache diary during the follow-up. After this initial treatment, participants with recurring headache can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique may be viable treatment option for chronic migraine and enable us plan for further studies on this treatment.	Migraine	Non applicable	Traitement symptomatique	Norway	À vérifier
Pleural embolisationThermal ablation is an established treatment for lung cancer. It involves insertion of a applicator under image guidance into a lung tumour and destroying it with radiofrequency, microwave or cryotherapy. One of the common side effects is pneumothorax, which is a leak of gas from the lungs when it punctured. Air leak necessitates placement of a drainage tube in more than half of patients undergoing the procedure. The drain can be associated with some morbidity including pain, reduced mobility, prolonged hospital stay and infection Pleural embolization refers to the injection of substances to the linings of the lung to seal air leakage. There is published evidence in using pleural embolization with autologous blood (blood drawn up from the patient's veins) to prevent pneumothorax in patients undergoing lung biopsies. This technique is also known as pleural blood patch (PBP). A study involving more than 4000 patients found that PBP reduced the rates of pneumothorax by 35% and drain placement by 55% in lung patients. A study using prophylactic gelfoam torpedo embolization for radiofrequency ablation showed significant reduction in chest drain rates. In this study, investigators plan to evaluate the PBP using a tandem needle technique in patients undergoing lung ablation at the Oxford Thermal Ablation Service, one of the largest units in the country performing about 200 ablations per year, mostly microwave ablations. Patients will be randomized to receive lung ablation with or without the PBP. The PBP technique is easy to learn, enjoys high technical success rates and does not expose the patient to any significant additional risk. The primary outcome is the chest drains rates in the two trial groups: 1. patients undergoing lung ablation without PBP and 2. patients undergoing lung ablation with PBP. Other outcomes that would be measured include the volume of gas leakage on Computed Tomography (CT) imaging, safety profile, length of stay, feasibility of same day discharge, patient oriented outcomes including validated pain score, and institution oriented outcomes including medical costs. A positive trial could significantly reduce the side effect profile of lung ablation and hasten the patient's recovery. There could be significant savings in healthcare costs as the procedure may become safe to perform as a day procedure as opposed to an overnight procedure.	Cancer	Non applicable	Traitement symptomatique	United Kingdom	À vérifier
CryoneurolysisThe trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine. Chronic migraine is a condition that causes moderate to severe headache. In this study, the investigators want to evaluate the freezing technique in chronic migraine. The main goal is to see how much headache relief is experienced after receiving the treatment. The investigators will also record other important information about the participants. The study is looking to recruit 12 adults with chronic migraine to take part in the study. Participants will register their headache burden in a headache diary for at least 4 weeks before receiving treatment with the freezing technique. They will continue to register headache in the headache diary during the follow-up. After this initial treatment, participants with recurring headache can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique may be viable treatment option for chronic migraine and enable us plan for further studies on this treatment.	SEP	Phase 4	Traitement symptomatique	United Kingdom	À vérifier
CryoneurolysisThe trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine. Chronic migraine is a condition that causes moderate to severe headache. In this study, the investigators want to evaluate the freezing technique in chronic migraine. The main goal is to see how much headache relief is experienced after receiving the treatment. The investigators will also record other important information about the participants. The study is looking to recruit 12 adults with chronic migraine to take part in the study. Participants will register their headache burden in a headache diary for at least 4 weeks before receiving treatment with the freezing technique. They will continue to register headache in the headache diary during the follow-up. After this initial treatment, participants with recurring headache can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique may be viable treatment option for chronic migraine and enable us plan for further studies on this treatment.	Cancer	Non applicable	Traitement symptomatique	United States	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
Cryoneurolysis	Cancer	Non applicable	NCT05444361	Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy	ENROLLING_BY_INVITATION
Cryoneurolysis	SEP	Phase 4	NCT07303582	ICE — Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities	RECRUITING
Pleural embolisation	Cancer	Non applicable	NCT06651658	OxPET — Oxford Pleural Embolisation Trial	RECRUITING
Cryoneurolysis	Migraine	Non applicable	NCT06554886	A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine	ACTIVE_NOT_RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.