ANZCTR search results

This study is a prospective, multicentre, first-in-human study to evaluate the safety and effectiveness of the Shockwave Medical VTL II System with VTL II Catheter and Aortic Steerable Sheath to treat participants with symptomatic, severe calcified aortic stenosis. Eligible participants who meet all inclusion and exclusion criteria and provide informed consent will undergo transcatheter aortic valve lithotripsy (TAVL) procedure using the VTL II System. The procedure is performed via a trans-vascular approach in a catheterisation laboratory or a hybrid suite, where lithotripsy (soundwaves) pulses are delivered to modify calcified aortic valve tissue. Additional balloon aortic valvuloplasty and transcatheter aortic valve implantation may be performed at the operators discretion. Participants will receive standard post-procedural care and be followed during hospitalisation and at discharge. Follow-up assessments will occur at discharge, 30 days, 6 months, 12 months and 24 months post procedure. Study exit will occur between 12 and 24 months following the index procedure.

Asthma attacks are a common reason children come to the Emergency Department. When inhaled treatments and steroids are not enough, doctors give stronger medicines through a drip. The two medicines used most often are magnesium and aminophylline, but despite their frequent use, we still don’t know which one helps children recover faster or reduces the need for extra breathing support. The MAGIC study will compare these two treatments in more than 1,000 children aged 2 to 15 years with severe asthma across leading hospitals in Australia and Aotearoa New Zealand. Each child will be randomly assigned to receive one of the medicines first; if their asthma remains severe, they may also receive the other. We will measure whether the first medicine works within four hours without needing more IV treatment or increased breathing support, and which treatment pathway leads to shorter hospital stays. We will also assess side effects, need for intensive care, satisfaction with care, quality of life and costs. The aim is to provide clear evidence to guide emergency doctors and update national guidelines in both countries, helping children recover more quickly and return home sooner.

Brief description of the study purpose: This study aims to assess the feasibility of implementing a digital, patient-led malnutrition screening tool for people undergoing jaw reconstruction surgery for head and neck cancer at Chris O'Brien Lifehouse. The study will also involve co-designing the tool with consumers, healthcare professionals, and information technology specialists. Who is it for? You may be eligible for the co-design phase of this study if you are a consumer advisory panel members with experience of head and neck cancer. You may be eligible for the implementation phase of this study if you are aged 18 years or older who are undergoing jaw reconstruction surgery for head and neck cancer at Chris O'Brien Lifehouse, are English-speaking, and have access to a mobile device and the internet. Study details: The study will be conducted in two phases. In Phase 1, consumer advisory panel members, including people with lived experience of head and neck cancer, will take part in a single online or in-person focus group lasting approximately 1 to 1.5 hours to help co-design the digital malnutrition screening tool. In Phase 2, patients undergoing jaw reconstruction surgery for head and neck cancer will test the digital screening tool before surgery. Participants will complete a short survey (by phone or SMS), use the screening tool, and complete a final online survey. Participation is expected to take approximately 30 minutes in total. All participants will receive the study intervention relevant to their phase of participation. The study involves completion of surveys and testing of the digital malnutrition screening tool. No additional blood tests or cancer treatments are required as part of the study. It is hoped that this research will support the development and implementation of an effective patient-led screening approach to identify malnutrition earlier and improve nutritional care for people with head and neck cancer.

This project aims to investigate whether physiotherapists can support people to return to run after stopping due to knee osteoarthritis. Twenty participants will be recruited and prescribed a running program along with fortnightly physiotherapy sessions (conducted in-person or using telehealth) to guide progression of running distance over 9-12 weeks, increasing toward 5km distance. Physiotherapists will offer advice and exercise to help support running. Pain and symptoms will be monitored and if needed treatment offered to participants. Running distance and number of runs completed will also be recorded. At the end of the project, participants will be invited to complete an interview with a researcher to understand their experiences taking part. Insights from these interviews and the success of recruitment and participation will form the results of this project to guide further research and inform the real-world use of physiotherapy-supported running programs in Australia.

This study will evaluate whether low-intensity support helps schools sustain the implementation of the SWAP IT healthy lunchbox program. The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, is cost effective and has been scaled-up to >900 primary schools across Australia. We will compare schools receiving sustainment support to those receiving usual care, assessing the proportion implementing the ongoing SWAP IT program as recommended at 6 month follow-up.

Hepatitis C remains a major public health issue, particularly for people who inject drugs, where staying engaged in care can be challenging. This study aims to assess whether offering small financial incentives can improve engagement with hepatitis C testing, treatment, and follow-up care. Using a single-site, non-randomised, single-arm design, participants receive incentives for collecting point-of-care test results. Those who test positive may receive further incentives for attending a pre-treatment clinic visit; collecting direct-acting antiviral medication; attending follow-up testing to confirm cure. The study hypothesises that this incentive-based approach is feasible, acceptable, and can support improved engagement across the hepatitis C care pathway.

This study is testing whether a hand-held light device can reduce the pain of needle injections into the skin. Each participant will have the light device placed briefly on one forearm, and a different, inactive-looking light device placed on the other forearm, before receiving a small injection on each arm. We expect that the arm treated with the active device will feel less pain during the needle insertion and injection than the arm treated with the inactive device. Pain will be measured straight after each injection using a simple 0–10 pain rating scale, and participants will also be asked about any side effects up to one week later. We hope this study will show whether this light-based device is a safe and effective way to reduce pain from injections.

Obstructive Sleep Apnea (OSA) is a highly prevalent condition that can lead to significant cardiovascular and metabolic complications if left untreated. While Continuous Positive Airway Pressure (CPAP) therapy is highly effective, long-term patient adherence remains a significant challenge, with many patients abandoning therapy within the first month. This study is a prospective non-randomized controlled trial designed to evaluate the impact of an intensive telemonitoring program on CPAP adherence over a 12-month period. Participants with moderate to severe OSA will be allocated into two groups:Intervention Group: Participants receive standard CPAP acclimatization plus intensive daily telemonitoring. Staff will proactively contact patients who show low usage to provide motivational coaching and troubleshooting. Control Group: Participants receive standard CPAP acclimatization and follow-up (usual care) through the public health system in Canberra.The primary objective is to determine if intensive telemonitoring improves the proportion of patients achieving clinical adherence at 12-months. Secondary objectives include assessing improvements in sleep-related functional status, as well as conducting a cost-benefit analysis of the telemonitoring intervention compared to usual care in the Australian Capital Territory.

Who is it for? This study is for patients aged 18 years or above who have planned curative-intent surgical resection for known or suspected pancreatic ductal adenocarcinoma or periampullary adenocarcinoma (including ampullary, distal bile duct, or duodenal adenocarcinoma) Study details This study will evaluate whether the fluorescent imaging agent VGT-309 can be safely and practically used during surgery for pancreatic and periampullary cancer. During surgery, credentialled pancreatic surgeons will perform near-infrared fluorescence imaging using a commercially available imaging system to assess the feasibility of incorporating VGT-309 fluorescence imaging into standard pancreatic surgery. Participants will receive a single intravenous infusion of VGT-309 (abenacianine) at a dose of 0.31 mg/kg (abenacianine sodium free equivalent). The infusion will be administered by clinical staff in a hospital setting. The study will identify whether VGT-309 helps locate the tumour and will compare the relationship between the timing of VGT-309 administration and intraoperative fluorescence image quality. Additionally, the study will compare intraoperative and ex vivo fluorescence imaging findings with routine histopathological assessment, including tumour presence, resection margin status, lymph node involvement, and metastatic disease. It is hoped that the findings of this study will inform the design of future clinical studies evaluating fluorescence-guided surgery for pancreatic and periampullary cancer.

Due to normal functional processes such as breathing and digestion, abdominal tumours and organs can move during radiotherapy. The purpose of this study is to determine whether a new software using artificial intelligence (AI) can be used during radiotherapy to track organ motion for more accurate treatment. Who is it for? You may be eligible for this study if you are an adult who is receiving radiotherapy for treatment of an upper abdominal cancer, for example pancreatic cancer, liver cancer or kidney cancer. Study details All participants in this study will continue to undergo their usual radiotherapy treatment schedule. Using AI, we will generate a customised ‘motion model’ specific to each participant. During radiotherapy treatment sessions, additional x-ray imaging will be collected. These images will be used to check the performance of this custom AI model. There will be no follow up of participants and the motion model will not be used to guide or impact treatment of the participant. It is hoped that this study will help researchers understand more about how AI may be safely used during abdominal radiotherapy. This knowledge may help improve the quality of treatment received by cancer patients in the future.