Hurstville

Researchers are evaluating two types of radiation treatments for women with small, node-negative breast cancer (3 cm or smaller) after breast-conserving surgery. The study aims to find out if partial breast irradiation (PBI) given once a day over one week is not worse than whole breast irradiation (WBI) in preventing cancer from coming back locally and if it leads to better cosmetic outcomes as assessed by patients three years after treatment. This is a phase 3 randomized trial focusing on the comparison of these two radiation approaches. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total radiation dose of 26 Gy divided into 5 daily sessions over 5 to 7 days (up to 8 days allowed due to holidays). The radiation is carefully targeted to the appropriate breast area, and the study is single-blinded so that patients do not know which treatment they receive to avoid bias in cosmetic assessments. Treatment planning includes using CT imaging and surgical markers for accurate delivery. During the study, participants will be monitored annually for five years to check for local cancer recurrence. Cosmetic outcomes will be assessed by patients themselves at three and five years post-treatment. Other evaluations include tumor characteristics and receptor status, and treatment safety will be observed. The total participation involves follow-up over several years to understand long-term effects of the treatments.

Researchers are evaluating the safety, effectiveness, and how the body processes VX-01 as an oral treatment for people with moderate to severe Non-Proliferative Diabetic Retinopathy (NPDR) without clinically significant diabetic macular edema (CI-DME). This Phase 2, multi-center study compares VX-01 to a placebo over 52 weeks, aiming to see if daily doses can improve the condition in adults with Type 1 or Type 2 diabetes. Participants will be randomly assigned to receive either VX-01 tablets (150 mg twice daily) or matching placebo tablets twice daily for one year. The study groups are balanced based on the presence of proliferative diabetic retinopathy and blood sugar control levels. After the 52-week treatment period, there is a 12-week follow-up phase where all participants continue to be monitored without the study drug. During the study, participants will have regular eye exams, including imaging and visual acuity tests, and blood tests to monitor safety and treatment effects. Researchers will track adherence to medication and evaluate outcomes such as vision changes and diabetic retinopathy progression. Safety and tolerability will also be closely observed throughout the treatment and follow-up periods, with total participation lasting about 64 weeks.

Researchers are evaluating VIA Disc NP, a minimally processed human nucleus pulposus tissue allograft, as a supplement for degenerated intervertebral discs in participants with symptomatic lumbar disc degeneration lasting more than 6 months and unresponsive to at least 3 months of conservative treatment. This Phase 2 randomized, double-blind, sham-controlled, multi-center study aims to assess the safety and effectiveness of VIA Disc NP compared to a sham procedure. Participants will be randomly assigned in a 1:1 ratio to receive either a single intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline at one or two affected levels (L1-S1) or a sham procedure where a needle is inserted through the skin and muscle but does not penetrate the disc annulus. The treatment is delivered once, targeting 1 or 2 lumbar disc levels. During the study, participants will be monitored for treatment effectiveness and safety up to 26 weeks. Effectiveness is measured by the proportion achieving a meaningful improvement in pain scores from baseline to 26 weeks, and safety by reported treatment-related adverse events up to 12 weeks. Assessments include pain severity (VAS), disability scores (ODI), neurologic exams, and patient-reported outcomes. The total participation age range is 22 to 85 years old.

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) at 100 mg/mL in people with neovascular age-related macular degeneration (nAMD). This study includes participants who have completed previous Phase II or Phase III studies or reached Week 24 in a related study but were not randomized. The study also explores two sub-studies: one assessing a laser treatment to reduce eye bleeding related to the PDS implant procedure, and another assessing the safety of re-implanting an updated PDS device. Participants receive the PDS implant with ranibizumab according to specific schedules in their study arms. The first sub-study uses transscleral photocoagulation with an Iridex laser system to reduce vitreous hemorrhages after implantation, enrolling about 55 participants. The second sub-study involves up to 100 participants in the United States who undergo re-implantation of the updated device and are followed for up to 72 weeks. Treatments and procedures are carefully monitored throughout. Participants undergo regular visits for up to 240 weeks to monitor for adverse events, including eye-related and systemic effects, severity, duration, and any device-related issues. The sub-studies also track specific complications like vitreous hemorrhages and adverse device effects during postoperative and follow-up periods. Safety assessments include eye exams, imaging, and evaluation of systemic health to ensure ongoing monitoring of participant well-being throughout the study.

Researchers are evaluating a new method of delivering Evoke Compound Action Potentials (ECAP)-controlled closed-loop spinal cord stimulation (SCS) using updated software and/or hardware features for people living with chronic pain in the trunk and/or limbs. This feasibility study aims to test and assess the novel treatment delivery with the Evoke SCS System to better understand its potential use for managing chronic pain. Participants will receive the Evoke Spinal Cord Stimulation System, which is a device that provides ECAP-controlled, closed-loop spinal cord stimulation. The study is single-arm and multicenter, focusing on patients who have already undergone or are planning to undergo implantation of the Evoke System within its approved use. The study does not include a comparison group. During the study, researchers will monitor changes in Evoke Compound Action Potentials (ECAPs) using the Evoke SCS System. Participants will be followed for up to two years to assess this primary outcome. Throughout participation, individuals will be asked to comply with study requirements and provide informed consent, with ongoing evaluation to understand the treatment's impact on chronic pain.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.

Researchers are evaluating the effects of ADX-038, a siRNA duplex oligonucleotide, in people with geographic atrophy (GA) caused by age-related macular degeneration (AMD). This Phase 2 study compares ADX-038 with a placebo to assess its ability to preserve the ellipsoid zone (EZ) layer in the eye over 12 months. The study also monitors safety, pharmacokinetics, and pharmacodynamics. Participants will receive subcutaneous injections of either ADX-038 or a saline placebo. The study is randomized, masked, and placebo-controlled, ensuring unbiased comparison between the two groups. The treatment period lasts for 12 months, during which participants will undergo regular clinic visits and follow study procedures. During the study, participants will have eye examinations and imaging to evaluate the condition of the GA lesions and the EZ layer. Researchers will track adherence to study visits and vaccinations required by the protocol. The main goal is to measure the effect of ADX-038 on preserving the EZ layer at 12 months, while monitoring safety and any adverse effects throughout the study.

Researchers are conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.

Erectile dysfunction (ED) is a common condition in men, often associated with reduced quality of life and linked to health issues like depression, diabetes, and cardiovascular disease. Researchers are evaluating the long-term safety and effectiveness of the Rigicon Infla10ae Three-Piece Inflatable Penile Prosthesis to treat ED. This study follows patients who receive this prosthesis for up to three years after implantation to gather comprehensive safety and efficacy data. Participants receive the Rigicon Infla10ae device, a patient-activated inflatable penile prosthesis designed to help achieve and maintain an erection. The study includes several follow-up visits at 14 days, 6 weeks, 6 months, 12 months, 18 months, 24 months, and 36 months after the procedure. During these visits, participants are monitored according to study protocols and standard care for ED and related health conditions. Throughout the study, researchers assess safety by tracking adverse events related to the device or procedure over a 12-month period. Effectiveness is measured by an objective test of penile rigidity at 12 months. Participants complete follow-up visits and tests to monitor outcomes and device function. The total study duration includes up to three years of observation to ensure long-term safety and performance.

Researchers are evaluating the ShiraTronics Migraine Therapy System in a pilot study to assess its preliminary safety and effectiveness in preventing chronic migraines for patients who have not responded well to other treatments. The study focuses on adults aged 22 years and older who experience frequent headaches and have a history of migraines lasting at least one year. This research aims to provide new options for those with refractory chronic migraine who have limited success with existing therapies. Participants will use the ShiraTronics Migraine Therapy System, a neurostimulator device designed to relieve, interrupt, and prevent chronic migraine attacks. The study does not specify multiple groups or comparators but emphasizes the evaluation of this device’s impact on migraine symptoms over a set period. The treatment will be monitored closely for safety and efficacy throughout the study. During the study, participants will be assessed based on the number of headache days they experience during 12 weeks of treatment. Researchers will track migraine frequency, safety outcomes, and overall response to the neurostimulator. Participants must maintain stable use of any migraine medication they are currently taking and will be monitored for any changes or side effects. The total duration and detailed procedures beyond the primary outcome measure are not specified but focus on observing the device’s effect on chronic migraine frequency and patient safety.