This study aims to investigate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared to the standard of care TAE/cTACE to treat a tumor by reducing or completely closing off the arterial blood supply to the tumor. The Instylla HES is an experimental treatment. Subjects will be evaluated for 180 days following the embolization procedure. At each visit, subjects will be asked to complete at least one quality of life questionnaire, undergo a physical assessment (vitals only), blood test to check blood cell levels, and follow-up tumor imaging. Throughout the duration of the study, subjects will be evaluated for complications or side effects that may be related to the procedure and/or Instylla HES device. This study will be conducted at up to 20 sites in the U.S. with additional sites outside of the U.S. It is anticipated that the full investigation will take approximately 2 years.
This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.
Patients who undergo elective colorectal surgery are at high risk for post-operative surgical site infection, and the majority of SSIs occur after hospital discharge when patients are responsible for their own wound care. A novel approach to post-discharge wound evaluation is Remote Wound Monitoring, a novel platform implemented through MUSC Health's established telehealth infrastructure, based on the successful implementation of Remote Patient Monitoring (RPM) for COVID-19 symptoms. This program was recently developed to enable patients to submit wound care observations and wound photos via MyChart at regular intervals after hospital discharge. Telehealth nurses review patient generated wound images, and brief survey responses from patients using a mobile smartphone, escalating any concerning findings to colorectal surgery clinic staff. The goal of the present study is to refine the RWM program using interviews and questionnaires with those who have used RWM in practice, including patients and colorectal surgery providers, to make the MyChart based questionnaire more "user-friendly." The RWM platform was designed to bring post-operative wound triage directly to the patient's home to address barriers to healthcare, including high cost, burden and time commitment (e.g., geographic limitations, transportation, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. During this project, we will perform semi-structured interviews of stakeholders who have used the RWM service in practice, including patients, colorectal surgery providers and telehealth nurse monitors, and administer measures of satisfaction/usability and patient quality of life, followed by consumer-driven adjustments to the service to ensure high acceptability and usability. Refinement will be aimed at improving patient adherence as well as provider barriers to implementation. The proposed project will aid in the development of technology-based resources that (1) improve the quality of and access to post-operative wound triage for surgical patients and (2) relieve the burden on surgical provider by shifting primary triage of wounds to the telehealth remote patient monitoring team, and facilitating escalation of care when wounds veer from expected post-operative healing. RWM has significant clinical utility and strong potential to influence access to care and alter the doctor-patient relationship, enabling healthcare providers to prescribe the right intervention at the right dose at the right time for each patient.
This study is being done to determine if N-acetylcysteine (NAC) will reduce the amount of pain medications needed after some types of spinal surgeries.
The purpose of this study is to examine if patients undergoing cardiac surgery have memories and thought processes during the surgery while unconscious. Participants' brain electrical activity will be monitored during surgery using an EEG. A portable tablet will show random images to participants and participants will wear headphones that will generate audio cues during surgery. After recovery from surgery, participants will undergo a 45 minute interview to assess any memories or experiences during surgery.
The purpose of this research study is to find out if a nerve block called the quadratus lumborum (QL) block can provide pain relief after hip replacement, similar to a lumbar plexus (LP) nerve block that we currently offer patients. There will be two groups in this study: one group will have the QL block placed and the other group will have the LP block placed.
This study will implement and evaluate the Enhanced Recovery in Children Pathway (ENRICH-P) for pediatric patients with inflammatory bowel disease. Participants (or participants' parent) will be asked to complete quality of life surveys pre-operatively and up to 6 weeks after surgery.
This is an Expanded Access (treatment) protocol to expand treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study). This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from deep partial thickness (DPT) and full thickness (FT) thermal burns. Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient's DPT and FT burns that comply with the entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will allow an evaluation of the patient's systemic safety by allowing treatment of the patient's entire deep burns. Patients enrolled in this trial will undergo daily vital signs and pain assessments for 1 week starting on the morning after the start of treatment. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed. There will also be a scar quality evaluation at 3 and 12 months post wound closure confirmation visit.