patient enrollment News
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CHROMED trial completed successfully
Restech, in its role of technical manager and together with all the partner of the project, successfully concluded the CHROMED trial. With 312 patients enrolled and studied for 9 months by 6 clinical centers in 5 EU Countries, CHROMED has been the largest international multi-center randomized control trial evaluating the effectiveness of an integrated telecare approach for COPD patients based on ...
By Restech Srl
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Caladrius Biosciences Provides Update on Phase 2b FREEDOM Trial of XOWNA® in Coronary Microvascular Dysfunction
BASKING RIDGE, N.J., May 23, 2022 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease, today announced that the Company has suspended patient enrollment in its Phase 2b study of XOWNA®, known as ...
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CARDIONOVUM announces the first Signature RCT patient enrollment
CARDIONOVUM announced today the first Signature Randomized Clinical Trial patient enrolment. On June 8th, in Sankt Gertrauden hospital in Berlin, Germany, the first Signature RCT patient has been enrolled. Dr. Ralf Langhoff, P.I. of the study, stated “I believe that this randomized study will confirm, once more, the efficacy and the safety of the Legflow® DCB in the daily treatment of ...
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Medis QFR continues to show superiority over standard angiography, after a FU-period of 2 years
In the September 2022 issue of JACC journals (https://www.jacc.org/doi/10.1016/j.jacc.2022.06.044), the FAVOR III China Study Group published a sub-study that was aimed to ascertain whether the beneficial outcomes of QFR® guidance for lesion selection during PCI is affected by diabetes status. From the total of 3825 patients enrolled, 1295 (33.9%) had diabetes. The study confirmed that the ...
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Ascelia Pharma suspends clinical activities in Russia
Ascelia Pharma AB (publ) (ticker: ACE) today announced that due to the Russian invasion of Ukraine, all clinical activities in Russia in the ongoing Phase 3 study SPARKLE are being suspended. As a consequence, the expected recruitment completion for the SPARKLE study is extended to 2022 (previously H1 2022). The consequences of Russia’s invasion of Ukraine are both grave and ...
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Update on Biosceptre’s Phase 1 Clinical Trial for First-in-Class Oncology Vaccine BIL06v
Biosceptres’ Phase I clinical trial for peptide vaccine BIL06v has now completed enrolment of the first cohort of ten patients at the first dose, and all enrolled patients have received treatment. The trial was initiated in August and, subject to a scheduled safety review this week, it is expected that recruitment of the second cohort will begin before end of November. ...
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First Patients Enrolled in Balt STEM Trial
Balt announced today that the first patients have been enrolled in the clinical trial; The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic subdural hematoma [NCT04410146]. This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a ...
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Symic Bio Announces Last Patient Enrolled in Osteoarthritis Phase 2b Study MODIFY3
DENMARK & SAN FRANCISCO, October 8, 2020 – Symic Bio, a biopharmaceutical company developing novel extracellular matrix targeting drugs, today announced that the last patient had been enrolled in its Phase 2b OA (osteoarthritis) study. The study, dubbed MODIFY3, is a double-blinded, randomized controlled trial investigating Symic Bio’s DMOAD (diseasemodifying OA drug) candidate, ...
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Symic Bio Announces First Patient Enrolled in Osteoarthritis Phase 2b Study
SAN FRANCISCO, March 1, 2020 – Symic Bio, a biopharmaceutical company developing novel extracellular matrix targeting drugs, today announced that the first patient had been enrolled in its Phase 2b OA (osteoarthritis) study. The study, dubbed MODIFY3, is a doubleblinded, randomized controlled trial investigating Symic Bio’s DMOAD (disease-modifying OA drug) candidate, SB-061 vs. ...
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Ascelia Pharma’s Food Effect Study with Orviglance successfully completed
Ascelia Pharma AB (publ) (ticker: ACE) today announced that the last patient visit has been completed in the study to evaluate the effect of food intake on the absorption of Orviglance (Mangoral). This Food Effect Study is part of the ongoing pivotal clinical program for Orviglance and will be included in the marketing authorization package to the health authorities including FDA and EMA. ...
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Aurealis Therapeutics Receives Clinical Trial Application Approval for AUP-16 Diabetic Foot Ulcer Patient Trial
Aurealis Therapeutics, a private biopharmaceutical company developing AUP-16, the three-in-one combination biologic drug for chronic non-healing wounds and regenerative diseases, announced today clinical trial application (CTA) approval of the AUP-16 phase 1 diabetic foot ulcer (DFU) patient trial by the German Health Authority Paul-Ehrlich-Institute. The company plans to enroll the first patient ...
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Bluewind Medical Ltd. Completes OASIS Study Patient Enrollment
Bluewind Medical, Ltd., developer of the innovative RENOVA iStim implantable neuromodulation device for treatment of urinary urgency incontinence, today announced the successful completion of patient enrollment in the OASIS pivotal clinical study that will be the basis by which the company will seek US-FDA (Food & Drug Administration) marketing clearance in the United States. OASIS is a ...
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InGeneron Initiates Pivotal Study for its Clinical Lead Program in Rotator Cuff Tendinopathy
InGeneron, Inc., a regenerative medicine and cell therapy company, announced today the enrollment of the first patients in a pivotal study evaluating InGeneron’s cell therapy as a way to treat partial thickness rotator cuff tears involving a partial tear in the supraspinatus tendon. The primary goal of the double-blinded, multi-center trial is to demonstrate the effectiveness of the ...
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Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or ...
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CoNextions Inc. Announces Patient Enrollment in Clinical Trial for CoNextions TR System in South Africa
CoNextions Inc. (www.conextionsmed.com) announced today that its has enrolled its first two patients in a multicenter, blinded, randomized clinical trial comparing the CoNextions TR System to standard of care suture repair for repair of Zone 2 tendon lacerations. The first two patients were enrolled at Groote Schuur Hospital in Cape Town, South Africa. Five fellowship trained hand surgeons will ...
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Transgene confirms the potential of its two innovative platforms and expects significant clinical results in 2022
TG4050 (myvac): First positive results from the two Phase I trials. Additional data to be presented at AACR 2022 in April. TG4001: First patient enrolled in Phase II study in June 2021. Active patient recruitment in Europe and trial initiation in the US. Interim analysis expected in Q4 2022. BT-001 (Invir.IO™): IND approval for Phase I/IIa trial in the US, ongoing enrollment in Europe. ...
By Transgene
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Miracor Medical starts PiCSO-AMI-I randomized study in EU
Miracor Medical SA (Miracor Medical) today announced the initiation and first patient enrollment in the PICSO-AMI-I study to evaluate the benefits of PiCSO® therapy compared with conventional PCI for the treatment of anterior STEMI patients. The first patient enrolled into this study was treated at Oxford Heart Center, Oxford, UK by Professor Adrian Banning, the principal investigator of the ...
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Patient Enrollment is Complete in the DOD-Funded Study of Extracorporeal Hemopurification of Critically Ill COVID-19 Patients
MARTINEZ, Calif. – PURIFY OBS, an observational study of critically-ill COVID patients treated with the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100), has recently completed enrollment. A multicenter effort led by the US Department of Defense (DOD) published interim results in April 2021. Observations included dramatic improvement in survival and reduction in median ICU ...
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News release: CVRx Completes Enrollment of the BeAT-HF Phase III Randomized Clinical Trial, Continues to collect Morbidity and Mortality Outcomes
MINNEAPOLIS, July 21, 2020 /PRNewswire/ — CVRx, Inc., a private medical device company, announced that the BeAT-HF phase III randomized clinical trial has completed enrollment in the post-market phase. CVRx has also enrolled the first patient in a heart failure (“HF”) registry which is designed to be a national repository of individual patient data from commercial BAROSTIM ...
By CVRx
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Reflow Medical Announces 510(K) Clearance For An Expanded Indication For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease
Reflow Medical, Inc., a California-based medical device company, has announced that they have received clearance from the FDA for an expanded indication for the Wingman™ Crossing Catheter after completing the Wing-IT clinical trial. The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip that creates a channel to help penetrate, or cross, the occlusion with a guidewire, ...
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