Hurstville

Researchers are studying women with a newly diagnosed invasive breast cancer that is node negative and 3 cm or smaller in size to compare two types of radiation therapy after breast-conserving surgery BCS. The study aims to see if partial breast irradiation PBI given once daily over one week is not worse than whole breast irradiation WBI in preventing cancer return and whether it results in better cosmetic outcomes. This is a randomized, single-blind trial focusing on local recurrence and patient-assessed cosmesis three years after treatment. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total of 26 Gy radiation in 5 fractions, given once daily over 5 to 7 days with up to 8 days allowed for scheduling reasons. PBI targets the tumor bed plus a margin of normal tissue, while WBI targets the whole breast. Patients will not know which treatment they receive to avoid bias in cosmetic assessments. Stratification factors include tumor size, estrogen receptor status, and clinical center. During the study, participants will be monitored for local recurrence annually for five years and will assess their cosmetic outcome at three and five years post-treatment. Researchers will also evaluate survival, disease-free survival, radiation side effects, and quality of life at various intervals. Clinical assessments and nurse evaluations of cosmesis will occur at three and five years. Overall, participant involvement spans several years with multiple follow-up visits to measure outcomes and safety.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are studying the use of VX-01, an oral medication, to treat people with moderate to severe Non-Proliferative Diabetic Retinopathy NPDR, a condition related to diabetes affecting the eyes. This Phase 2 clinical trial aims to evaluate how effective and safe VX-01 is compared to a placebo over one year of treatment, including how the body processes the drug and its effects on the disease. Participants will be randomly assigned to one of two groups one group will receive VX-01 tablets at a dose of 150 mg twice daily, and the other group will receive placebo tablets twice daily. The treatment period lasts 52 weeks, followed by a 12-week follow-up after treatment ends. The study is double-masked, meaning neither participants nor study staff know which treatment is being taken during the trial. During the study, participants will have their vision and eye health regularly assessed using standardized tests such as the Early Treatment Diabetic Retinopathy Study ETDRS letter score and diabetic retinopathy severity scores. Safety will be monitored by tracking any adverse events. Participants must attend scheduled visits for evaluations and agree to avoid other investigational studies during the trial. The main goal is to see how VX-01 affects diabetic retinopathy after one year of daily treatment.

Researchers are evaluating TO-O-1007, a biodegradable sustained-release intravitreal implant, for the treatment of Geographic Atrophy GA caused by Age-related Macular Degeneration AMD. The study is designed to assess the safety, tolerability, pharmacokinetics, and early effectiveness of this implant. TO-O-1007 aims to provide a long-lasting treatment option that may slow the progression of GA lesions and reduce the need for frequent eye injections. Participants will receive one of several treatments a low-dose or high-dose TO-O-1007 implant injected into the eye, or a sham injection to maintain masking. The implant gradually degrades, releasing medication over approximately six months. This study includes two phases Phase I and Phase IIa with different dosing groups to evaluate the implants effects and safety compared to a sham treatment. During the study, participants will undergo eye exams to monitor lesion growth and visual function at multiple time points, including baseline, 12 weeks, and 24 weeks. Safety will be closely watched through treatment-emergent adverse event recording up to six months. Pharmacokinetic sampling will be done at several intervals to measure drug exposure. The total study duration extends up to 28 weeks with regular visits for assessments and monitoring of the implants effects on vision and eye health.

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab PDS in people with neovascular age-related macular degeneration nAMD. This study includes participants who have completed earlier related studies or met specific criteria in a recent study. Two sub-studies are included one assessing the use of transscleral photocoagulation TPC to reduce vitreous hemorrhages after PDS implantation, and another evaluating the safety of re-implanting an updated PDS device. Participants will receive PDS implants and undergo refill-exchanges of ranibizumab at various intervals, mostly every 24 weeks Q24W, with some switching to every 12 weeks Q12W visits later in the study. The transscleral photocoagulation sub-study involves PDS implantation using TPC followed by ranibizumab refills. The re-implantation sub-study includes follow-up for up to 72 weeks after receiving the updated implant and scheduled refill-exchanges. During the study, participants will attend scheduled visits for treatment and assessments lasting up to several years. Researchers will monitor ocular and systemic adverse events, focusing on the severity and duration of side effects related to the device and treatment. Vision and eye health will be regularly evaluated using tests like best-corrected visual acuity and imaging. Safety data from the sub-studies will also be collected, including rates of vitreous hemorrhage and other ocular events, with study participation extending until regulatory decisions or study closure.

This research aims to evaluate a new delivery method of spinal cord stimulation using the Evoke System for patients with chronic pain in the trunk andor limbs. The study focuses on a novel approach called ECAP-controlled closed-loop spinal cord stimulation, which includes new software and hardware features to better manage pain. The trial is designed as a prospective, multicenter, single-arm feasibility study sponsored by Saluda Medical Pty Ltd. Participants will receive treatment with the Evoke Spinal Cord Stimulation SCS System, which continuously measures and records evoked compound action potentials ECAPs and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. This closed-loop system aims to provide a more personalized and controlled pain management experience. The study includes only one experimental treatment group using this device. During the study, participants will be closely monitored for changes in ECAPs as measured by the Evoke SCS System through the completion of the study, which can last up to two years. Assessments will focus on the devices performance in controlling pain signals, with ongoing evaluations to track the stability and effectiveness of the stimulation. Participants will provide informed consent and comply with study requirements throughout their involvement.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.

Researchers are evaluating the effectiveness of ADX-038 compared with a placebo in people aged 60 and older who have geographic atrophy GA caused by age-related macular degeneration AMD. This Phase 2 study also aims to assess the safety, how the body processes the drug pharmacokinetics, and how the drug affects the body pharmacodynamics. Participants will be randomly assigned to receive either the active drug ADX-038, which is a siRNA duplex oligonucleotide, or a saline placebo through subcutaneous treatment. The study follows a parallel design with quadruple masking to compare the effects of the treatments over time. During the study, participants will attend clinic visits for various assessments including imaging to evaluate the preservation of the ellipsoid zone EZ layer in the eye over 12 months. The study team will monitor safety and adherence, and participants must complete meningococcal and pneumococcal vaccinations as required. The total study duration extends until 2030, with the primary outcome measured at 12 months.

Researchers are conducting a global, prospective, multi-center observational study to gather real-world data on the long-term effectiveness, economic value, and technical performance of Boston Scientifics commercially approved neurostimulation systems for pain management. The study focuses on patients using these neurostimulation devices according to their approved instructions for use in routine clinical practice. Participants will first undergo a neurostimulation trial period using any commercially approved Boston Scientific neurostimulator for pain. Those who experience a positive outcome from this trial may then receive a permanent implant of the neurostimulation system. Treatment customization will be guided by the investigators judgment and routine care practices at each site. During the study, participants will be observed to collect information on clinical outcomes, technical device performance, and economic factors related to neurostimulation therapy. The research team will monitor participants over the long term to assess how well the therapy manages pain and its associated benefits. The study is expected to continue until May 2035, with ongoing follow-up and data collection throughout this period.

This research aims to evaluate the long-term safety and effectiveness of the Rigicon Infla 10 Three-Piece Inflatable Penile Prosthesis in men with erectile dysfunction ED. ED is a common male sexual condition linked to various health issues such as diabetes, cardiovascular disease, and depression, affecting quality of life. The study follows patients implanted with this device for up to three years to assess its impact on ED treatment. Participants receive the Rigicon Infla 10 inflatable penile prosthesis, which is a three-piece device designed to help men achieve and maintain erections. The study involves a single group of male subjects aged 22 and older who have been implanted with this device. Follow-up visits are scheduled at 14 days, 6 weeks, 6 months, 12 months, 18 months, 24 months, and 36 months post-implantation to monitor safety and device effectiveness. During the study, participants will have assessments including device-related safety events, an objective axial rigidity test at 12 months, and evaluations of erectile function and self-esteem using standardized questionnaires. Researchers will monitor participants according to the study protocol and usual care for ED and related health conditions. The total participation period spans up to three years with periodic health evaluations and device durability assessments.