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A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Rochester, MN
The purpose of this study is to determine feasibility of Kerecis intact fish skin for healing of fistula-in-ano and associated non-healing draining wounds.
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Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Jacksonville, FL
The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
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Evaluation of the Vaginal and Rectal Microbiome in Patients with Rectovaginal Fistula
Rochester, MN
The aim of this study is the characterization of the vaginal and rectal microbiome in women undergoing surgical repair of rectovaginal fistula.
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A Study Of Using Mesenchymal Stem Cells Developed From The Patients Own Fat Tissue For Reducing Hemodialysis Arteriovenous Fistula Failure
Rochester, MN
The purpose of this study is to determine the success of mesenchymal stem cells, developed from the patient's own fat tissue, for reducing hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.
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SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Rochester, MN
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
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Vedolizumab IV 300 Mg In The Treatment Of Fistulizing Crohn's Disease
Rochester, MN
The purpose of this study is to evaluate perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).
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A Study To Analyze AVB-114 To Treat Complex Crohn’s Perianal Fistulas In Subjects With Quiescent Rectal Disease
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether AVB-114 compared to standard of care treatment is effective in inducing remission of the treated complex perianal fistula in subjects with Crohn’s Disease. It also aims to assess clinical and radiologic components of fistula remission, safety of treatment, disease activity, patient Quality of Life, and patient care journey, between AVB-114 and standard of care treatment.
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A Study To Assess Adult Allogeneic Expanded Adipose-derived Stem Cells (EASC) For The Treatment Of Complex Perianal Fistula(s) In Patients With Crohn's Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.
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A Study To Evaluate The Safety And Effectiveness Of Adult Allogeneic Expanded Adipose-derived Stem Cells (EASC) For The Treatment Of Complex Perianal Fistula(s) In Patients With Crohn's Disease
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.
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Pediatric MSC-AFP Sub-study For Crohn's Fistula
Rochester, MN
The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.
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Phase 1 Crohn's Pediatric Sub-study of MSC AFP
Rochester, MN
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure ...
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DialySafe Device LED Light Assessment for Transillumination
Jacksonville, FL
The purpose of this research is to gather information on the effectiveness of an innovative device called the “DialySafe” intended to help reduce the chance of needle infiltrations during hemodialysis procedures. The DialySafe concept is a light-based device intended to make the AV fistula and graft easily visible for needle insertion. Light is generated from a red LED embedded in the surface of the device. The device will use transillumination technology to visualize the access, which consists of shining light directly into the skin where blood absorbs some of the light, resulting in a true representation of the ...
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A Study To Evaluate Darvadstrocel In The Treatment Of Complex Perianal Fistula In Crohn's Disease Patients
Rochester, MN
The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
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Feasibility Study Comparing the Utility of GLOW800 and FL800 Intraoperative ICG-VA Tools for Intracranial Lesions
Scottsdale/Phoenix, AZ
The purpose of this study is to comparatively evaluate the use of the GLOW800 visualization tool for ICG-VA versus the standard of care visualization tool FL800.
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Florida Cerebrovascular Disease Biorepository and Genomics Center
Jacksonville, FL
The aim of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida. The Center will collect and store detailed phenotypic information, DNA, and other biofluids on affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid ...