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Radiation Exposure clinical trials

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NCT ID: NCT04689373 Completed - Dehydration Clinical Trials

Physical and Cognitive Effects of Fluoroscopy

Start date: June 30, 2021
Phase:
Study type: Observational [Patient Registry]

Background and objectives: The researchers will perform this study to reveal the clinical meaning of fatigue, headache, diarrhea, and impaired cognitive functions that are often expressed verbally in healthcare professionals who are exposed to fluoroscopy. Methods: After obtaining written informed consent, 84 samples will be included in the study. For operating room employees who meet the criteria determined before and after the operation; mini-mental state examination, weight, heart rate, non-invasive blood pressure value, VAS score for headache, radiation exposure time on fluoroscopy device, Rad measurement with the help of personal dosimeter before and after surgery, and total time in the operating room will be recorded.

NCT ID: NCT04678258 Recruiting - Radiation Exposure Clinical Trials

Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

ZERO MAGIC
Start date: November 30, 2020
Phase: N/A
Study type: Interventional

Catheter ablation of the cavo-tricuspid isthmus (CTI) is the curative first-line therapy for typical atrial flutter. Currently, two approaches are used in clinical practice. In contrast to the conventional linear ablation approach, the Maximum voltage-guided (MVG) strategy aims to limit ablation to high voltage areas (HVAs) representing the detectable correlate of relevant conducting bundles. Data from registries show that the MVG technique is sufficient to reach comparable clinical outcome with significantly shorter ablation duration when compared to the conventional linear strategy. Despite growing evidence, however, data from properly powered prospective randomized trials are lacking and the linear approach still remains standard. In addition, data on radiation exposure are controversial. As a substrate-based approach, the MVG strategy requires detailed mapping and signal analysis for identification of the individual architecture and exactly targeted energy application. However, the spatial mapping resolution of large tip catheters is limited. The use of the MicroFidelity catheter technology (IntellaMiFi) with high resolution mini-electrodes at the 8 mm catheter tip can be expected to further improve the feasibility of a voltage-guided approach. In addition, the MVG approach theoretically may encompass an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is needed to further evaluate this issue. Objective of this prospective randomized study is evaluate the performance of the micro-sensor technology for zero-fluoroscopy voltage-guided ablation of typical atrial flutter (AFL) compared with a population undergoing conventional linear ablation including a predefined invasive re-evaluation of persistent CTI block in addition to clinical follow-up. The study has been approved by the responsible ethics committee.

NCT ID: NCT04670016 Recruiting - Radiation Toxicity Clinical Trials

HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers

Start date: July 2, 2020
Phase:
Study type: Observational [Patient Registry]

Although many children with brain tumours are successfully cured of their disease, a substantial proportion of patients suffer disease recurrence and require further treatment. This therapy may involve a repeat course of radiation (RT2). Based on retrospective data, re-irradiation may provide palliative and even potentially curative benefit. However, such retrospective data are subject to bias, which may over-report survival and under-report toxicity. Furthermore, we do not know how re-irradiation affects patients' HRQOL. The goal of this research is to prospectively describe the HRQOL of patients diagnosed with DIPG and recurrent brain tumors and their families before and after re-irradiation to more accurately assess the benefit versus the toxicity of this treatment. In addition, if we are able to demonstrate the feasibility of collecting HRQOL information on a routine basis we will be able to justify the need to conduct this research further and implement HRQOL screening as a standard of care for these patients. Re-irradiation for children with DIPG and recurrent brain tumours will not cure these children from their disease but may improve neurological function and wellbeing. We postulate that the opportunity of more time to say the final good bye and creating memories will facilitate bereavement and prevent psychological dysfunction of parents and siblings. A greater understanding of what helps these families may enable clinicians to better support these children and their families in this difficult disease course. Ultimately our goal is to improve the psychological experience of these patients and their families.

NCT ID: NCT04527445 Not yet recruiting - Overactive Bladder Clinical Trials

Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Start date: June 30, 2024
Phase: N/A
Study type: Interventional

Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings. The radiation exposure will be compared between the two groups.

NCT ID: NCT04441320 Recruiting - Radiation Exposure Clinical Trials

Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A prospective, multicenter and controlled study to observe the efficacy and safety of coated metal ureteral stent in the treatment of radiation induced ureteral stricture.

NCT ID: NCT04404257 Completed - Radiation Exposure Clinical Trials

Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation

REDEFINE
Start date: November 5, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the ControlRad system device when installed in Fluoroscopic (x-ray) machine reduces radiation dose to operators (Doctors and nurses) and to the patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant procedures.

NCT ID: NCT04403815 Not yet recruiting - Radiation Exposure Clinical Trials

Radiation Exposure During Coronary Procedures According to Vascular Access

Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

Trial's objective is to evaluate: i. if there's any difference between the operator radiation exposure during diagnostic coronary angiography and/or percutaneous coronary intervention (PCI) performed through right-side artery accesses (wrist transradial access and distal transradial access) versus left distal radial artery access ii. the relationship between operator radiation exposure and other clinical and procedural characteristics, to assess independent predictors of operator radiation exposure. Design of the study: prospective multicenter observational cohort registry (OCR). The purpose of this OCR is to assess the radiation exposure of interventional cardiologist during a diagnostic coronary angiography and/or PCI according to vascular access used (see above). Coronary angiography and PCI will be performed according to usual practice

NCT ID: NCT04396158 Not yet recruiting - Radiation Exposure Clinical Trials

Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.

NCT ID: NCT04389190 Not yet recruiting - Clinical trials for Coronary Artery Disease

Radiation Dose Reduction Using Advanced Fluoroscopy Options in Coronary Cath Lab

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Fluoroscopy is integral part of diagnostic and therapeutic cardiac procedures. Among medical personnel, interventional cardiologists have the highest per head per year exposure to ionizing radiation which is two to three times greater than the radiologists. Although the patients' exposure is well below the level associated with increased cancer risk, yet as mentioned above, any exposure can be harmful and must be minimized using all possible dose reduction methods under the principle of 'As Low as Reasonably Achievable' (ALARA). Radiation exposure is influenced by factors that are dependent on patient (weight, body habitus), procedure (access site, procedure complexity, use of protective shielding, collimation) and equipment (overall quality control, field of view, beam filters thickness, pulse rate etc.). In fact in modern fluoroscopic equipment, several settings are customizable to aid reduce total emitted X-ray dose. In a diverse coronary lab as Tabba Heart institute, in addition to training the lab staff on reducing radiation exposure and use of protective gear, employment of a modern X ray system Like Toshiba (Infinix i8000V, Toshiba America Medical Systems, Inc.); equipped with customizable radiation dose reduction technologies and DTS, provides the interventionists an essential tools to ensure the highest radiation safety standards. Data is still scanty to show the difference in patients and operators' radiation exposures by using tailored equipment settings. We aim to apply customized fluoroscopy protocols based on low fps and other customizable settings (thickness of the spectral beam filters, peak tube voltage and peak cathode current, live zoom (1.4 factors with 12 inch FOV), fluoro store and Spot fluoroscopy) and then assess if they significantly affect the radiation exposure of the patient and the interventionist.

NCT ID: NCT04363190 Completed - Radiation Exposure Clinical Trials

Genomic Instability in Vascular Surgeons

IRADIENT
Start date: November 9, 2018
Phase:
Study type: Observational

The past two decades have witnessed the development and growth of the endovascular techniques, however, this new technology is not exempt from risks, since its use requires an ionizing radiation exposure to both patients and surgeons. In this context, the long-term repercussion of this type of chronic exposure to low dose ionizing radiation of the vascular surgeons is still unknown. Although conventional dosimetry is used to monitoring the occupational radiation exposure, it doesn't take into consideration a number of individual variables such as: age, sex, exposure to other carcinogen substances or previous medical history; that may affect the radio-sensibility of each individual. Some studies suggest the use of routine cytogenetic analysis to complement the conventional dosimetry, yet the real genomic effects of chronic low dose ionizing radiation exposure is still unclear and an ideal biodosimetry marker hasn't been described. In this setting, the main objective of the present study was to determine the genomic instability associated to the chronic low dose exposure to ionizing radiation of vascular surgeons versus healthy control patients with no history of radiation exposure. The secondary endpoints were to determine the impact of demographic and clinical practice activities associated to genomic instability among both groups of patients. National, observational and transversal case control study of genomic instability among vascular surgeons chronically exposed to low dose ionizing radiation compared to healthy control patients with no previous history of radiation exposure. The peripheral blood samples of the case group were collected from vascular surgeons during the VI International Symposium of Endovascular Surgery. The blood samples were followed by a demographic and endovascular practice questionnaire. On the other hand, the samples for the control group were collected from healthy patients undergoing saphenectomy and/or phlebectomy in our department at Hospital Clínico Universitario de Valladolid. All blood samples were send to the Cancer Investigation Center at Salamanca University where three types of genomic analysis were performed: (1) fluorescence in situ hybridization (FISH) study in interphase for the chromosomes 3, 7 and 17 and locus 9p21; (2) metaphase study with G banding technique; and (3) sister chromatid exchange (SCE) metaphase study.