Rheumatoid Arthritis Clinical Trials

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Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter

NCT06242600

The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use. The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events. The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter. Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire. Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.

Safety of the CytaCoat LIP Foley CatheterTolerability of the CytaCoat LIP Foley Catheter

CytaCoat AB30 participantsStarted Jan 2024

Gothenburg, Sweden

Not Yet RecruitingEARLY Phase 1

A Pilot Study on the Safety and Efficacy of YOLT-204 for Transfusion-Dependent Beta-Thalassemia

NCT06678165

This study is a single-arm, open-label, dose-escalation trial, planning to enroll 3-9 patients with transfusion-dependent β-thalassemia, aimed at assessing the safety and tolerability of a single-dose of YOLT-204 in patients with transfusion-dependent β-thalassemia; to preliminarily evaluate the impact of a single -dose of YOLT-204 on the levels of fetal hemoglobin in the plasma

Transfusion Dependent Beta Thalassemia

First Affiliated Hospital of Guangxi Medical University3 participantsStarted Dec 2024

Nanning, Guangxi, China

Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter

A Pilot Study on the Safety and Efficacy of YOLT-204 for Transfusion-Dependent Beta-Thalassemia

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