This study will optimize the DeepView SnapShot Portable device by imaging patients' burn wounds. These images contribute to the machine learning technology that will one day be used to aid burn clinicians in their treatment plans. Patients will be approached by the burn study team at the hospital when they initially come in for a burn wound treatment. Duration of the study for patients is 21 days.
This study is enrolling participants with severe aortic stenosis, which is narrowing of one of the heart valves. This condition reduces the amount of blood that can get to the body. This study is collecting data on the safety and effectiveness of an investigational (not yet approved for commercial use by the US FDA (Food and Drug Administration)) device called the ACURATE Aortic Valve System. The procedure to place the device, referred to as TAVR - transcatheter replacement of aortic valve is done in place of open heart surgery. In this study the ACURATE Aortic Valve System will be compared to two commercially available Aortic Valve Systems (valve replacement systems). Participants will be randomized (assigned by choice, like a flip of a coin, in a 1:1 fashion so 50% chance of being assigned to either group like the flip of a coin) to one of two groups. One group will receive the ACURATE Aortic Valve System while the other group will receive one of the commercially available systems. This study will last up to 10 years. Pre-procedure testing is done and reviewed by an eligibility committee to confirm you qualify. Study visits will occur prior to your procedure, during the procedure and throughout your hospital stay, and prior to discharge. Additional visits will occur 1 month and 6 months after your discharge, and then you will either seen or telephoned once per year for the next ten years. Study related testing includes CT scans, physical exams, echocardiograms (ultrasound test of the heart), blood work, and questionnaires.
This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart. This five year study will include a screening process to determine you meet eligibility criteria. If you qualify you will then be seen for a baseline visit, undergo the procedure to place the device, day after procedure, at hospital discharge, 1,3,6, 12 months, then yearly for up to 5 years. Study related testing includes physical exams, medication review, 6 minute hall walk test, questionnaires, blood work, CT scans, electrocardiogram or ECG (recording of your heart's electrical activity) and echocardiogram (ultrasound test of your heart).
The study will include 9 key informant interviews discussing how patients developed their impression of the benefit of an implant and how patients prefer expectation data be relayed. No video recordings will be performed during interviews. Interview notes or audio recordings will be taken and uploaded into a password protected network server. The results of interviews will mainly be descriptive. To test the plasticity of preoperative patient expectations and the impact of the CI evaluation the CIQOL expectations form will be administered prior to CI evaluation, directly after the CI evaluation, and prior to surgery for all patients who are undergoing cochlear implantation and meet inclusion/exclusion criteria and agree to participate. The decisional conflict scale will also be administered directly after the CI evaluation and prior to surgery for the above patient group. The 9 patients who undergo key informant interviews will also be part of the larger study group of 200 patients and have the same surveys administered and be subject to the same inclusion/exclusion criteria. The group of patients will also be asked about how they prefer expectation and QOL data to be relayed. All survey data will be collected in a secure RedCap database. Patients expectations at the three preoperative timepoints will be compared using paired T-tests. Data regarding how patients develop expectations and how they prefer expectation data to be presented to them will be mainly qualitative and discussed in terms of the most common themes from patient surveys and interviews. When exploring how patients prefer expectations and QOL data to be relayed we intend to include numbered clinical vignettes relaying differing levels of hearing capability. We will compare relaying information through vignettes to more conventional outcome measures such as speech recognition and QOL scores to determine which is the more effective means of communication.
This purpose of this study is to evaluate a new device called Lava Liquid Embolic System (LES) in the treatment of peripheral arterial hemorrhage (active bleeding in vessels outside of the head, heart, spine, and vessels related to childbirth). As an investigational device, Lava LES is not FDA approved.
The Lava LES device provides a minimally invasive type of treatment inside the vessels called embolization therapy that reduces or blocks blood flow to blood vessels or organs in order to stop internal bleeding. Subjects who have hemorrhage (bleeding) in a peripheral artery, including arteries located in the gastrointestinal system (stomach, intestines), lungs, liver, pancreas, spleen, prostate, bladder, uterus, muscles, or other peripheral artery wound caused by medical intervention or trauma, may be eligible for treatment with Lava LES.
The primary effectiveness goal is clinical success. Clinical success is defined as absence of bleeding from the wounded vessel after embolization with the Lava LES, without the need for emergency surgery, repeat embolization, or other medical intervention at the wounded vessel within 30 days of the embolization procedure. Subjects will be evaluated for 30 days following the embolization procedure for complications or side effects that may be related to the procedure and/or Lava LES device. The primary safety endpoint is freedom from major adverse events for 30 days. This is a first-in-human investigational trial.
Subjects will complete 4 visits (screening, embolization procedure, discharge, and 30-day follow-up). The 30-day follow-up will be completed remotely (video call or phone call). Some visits may occur on the same day. Participation in the study is anticipated to last about 30 days following the embolization procedure.
The objective of this study is to evaluate the efficacy of augmenting traditional autografting with Stratagraft. Stratagraft is a synthetic human-tissue based regenerative skin device, which was designed to decrease the amount of donor tissue needed to treat severe burn wounds. Patients who participate in this study are asked to complete assessments, such as wound photography, wound healing progression, and scar progression, at multiple timepoints during a 1 year period.
Potential participants are people who have been on medications to treat heart failure, but you continue to have symptoms and qualify to have the FDA approved BAROSTIM NEO™ System implanted. The purpose of this research study is to describe the safety and effectiveness of the delivery system by an ultrasound guided implant procedure in people with heart failure. This is an experimental implant procedure where the data collected during and after procedure will help confirm the safety and effectiveness of the new implant procedure. This will be the first time humans will be implanted using this experimental procedure.
This is a randomized study to evaluate the clinical performance of RECELL for re-pigmentation of stable, de-pigmented skin in subjects 18 years or older. RECELL is a device that takes a small sample of skin from one location on the participant's body, processes that sample into a spray, and then applies that spray to the depigmented skin on the participant's body. Each participant will have some depigmented skin that is not treated by the RECELL device, so that a comparison can be made to the treated areas. The participant will be asked to return for a follow-up visit 1, 4, 12, 24, 36, and 52 weeks after their treatment, so that the research study team can assess their outcome.
The purpose of this research study is to gather information on the health outcomes of patients who receive treatment with the Shockwave Medical, Inc Peripheral Lithoplasty® (Shockwave device) to assist with aortic endovascular procedures requiring a large catheter (long, thin tube made from medical grade materials). An endovascular procedure is a procedure where a doctor uses a small cut to insert a catheter into a blood vessel to repair it. The Shockwave Medical, Inc Peripheral Lithoplasty® system is an FDA approved catheter device used to open narrowed blood vessels in the legs (called arteries) so that it is easier for blood and other catheters to pass through. This study will collect information from participants who need an endovascular procedure on their aorta. The small cut used to insert the catheter is usually made in an artery in your leg and is used to get to your aorta. Endovascular procedures on the aorta use large catheters. Sometimes, it is necessary to expand the blood vessel in your leg so that the large catheters can fit. There are many different methods used clinically for this purpose, but it is not known which method works best. This study will help to determine if using the Shockwave device to expand your blood vessel is a better than using balloon angioplasty (use of a catheter with a balloon on the end) to expand your vessel