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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
AVITA Therapeutics States 1st Patient Enrolled in Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo
AVITA Therapeutics Chief Executive Officer, “The initiation of the vitiligo clinical study is a milestone in advancing AVITA Therapeutic’s pipeline to leverage the utility and full potential of our innovative RECELL technology platform to address unmet medical needs in dermatological applications.
Concept Medical Reports Index Patient Enrollment in World’s 1st RCT with Sirolimus Coated Balloon
Concept Medical notes the index patient was successfully enrolled on 11th September in Singapore.
NaviFUS Launches Neuronavigation-guided Clinical Trial to Open the Blood-Brain-Barrier for Combination FUS-Bevacizumab Therapy in rGBM Patients
NaviFUS Corporation notes researchers at Linkou Chang Gung Memorial Hospital are investigating the use of Neuronavigation-guided FUS to repeatedly and temporarily open the blood-brain barrier and enhance bevacizumab's efficacy in patients with recurrent glioblastoma.
Direct Biologics Initiates Patient Enrollment in the Phase II EXIT COVID-19 Clinical Trial
EXIT COVID-19 has initiated enrollment of 75 COVID-19 patients with moderate-to-severe ARDS at multiple research sites across the U.S. The primary efficacy endpoints will be all-cause mortality and median days to recovery.
NeuroSense Therapeutics Announces Encouraging Interim Results of Clinical Study in ALS
The study, containing 15 patients, is scheduled to continue for an additional 6 months.
12-Month Data Published in the American Journal of Respiratory and Critical Care Medicine, Demonstrate the Safety and Feasibility of RheOx ™ Bronchial Rheoplasty System...
The study assessed safety, changes in airway histopathology and quality of life. Performed using a minimally invasive bronchoscopic procedure called Bronchial Rheoplasty, the RheOx System delivers non-thermal pulsed energy to the airways in the lungs to reduce mucus-producing cells, improving the symptoms of cough and mucus.
Concept Medical Enrolls the First Patient in the TRANSFORM-1 RCT for MagicTouch Sirolimus Coated Balloon
TRANSFORM-1 is a prospective, randomized, multi-center, European study focusing on coronary artery lesions in small vessels with a head-on comparison between sirolimus coated MagicTouch and paclitaxel-coated SeQuent Please NEO of B. Braun. 114 patients are planned to be randomized 1:1 for Magic Touch or SeQuent Please NEO.
Results of the DCLP5 Study of the International Diabetes Closed Loop Trial Published in the NEJM: t:slim Insulin Pump with Control-IQ Technolog
The DCLP5 study was the first-ever large-scale, closed-loop pediatric study that included a dedicated control group.
Pilot Study Underway to Investigate Use of Attune Medical’s ensoETM for COVID-19 Treatment
ensoETM is a single-use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature.