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Venous Disease clinical trials

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NCT ID: NCT06433024 Not yet recruiting - Venous Disease Clinical Trials

Training of a Artificial Intelligence Model to Detect Venous Diseases Using PPG Technology

Start date: June 2024
Phase:
Study type: Observational

This clinical research aims to evaluate the effectiveness of using Photoplethysmography (PPG) signals combined with Artificial Intelligence (AI) algorithms, for the precise classification and diagnosis of Venous Diseases of the lower limb. This study invites a group of participants who currently undergoing investigations for venous disease at The Whiteley Clinic (hereinafter referred to as TWC). The Participants will be classified into control (healthy individuals with no significant venous disease) and chronic venous disease (CVD) (diagnosed with proven venous disease) groups. Prospective participants who express an interest in being included in the study will be given a patient information sheet and will undergo a briefing of the pilot study. If they consent and sign the relevant consent forms, the participants will perform a series of standardized exercises under the supervision of a consultant vascular surgeon. Throughout the exercises, a data acquisition device attached to the ankle records the PPG signals, capturing the changes in blood volume due to the reflected PPG signals from the red blood cells during the movement. Thus, once the data is collected and recorded, this allows for the analysis of the data of the control group and CVD group against each other. During the analysis of the two groups' PPG signals, the objective lies within the capability to detect subtle nuances in the patterns of the PPG signals during the performed movements using AI algorithms. The AI algorithms will distinguish patterns or features indicating the presence or absence of venous disease. This study seeks to contribute valuable insights into enhancing the diagnosis of venous disease using PPG and AI algorithms, paving novel approaches to Venous healthcare.

NCT ID: NCT06395025 Completed - Quality of Life Clinical Trials

Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group

Start date: October 17, 2023
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess in vivo the efficacy of the insoles, in improving venous return in subjects affected by this problem after 14 days of the initial measurements, by self-assessment, filling-in questions regarding Quality of Life, in comparison with a control group. The secondary goal of this study is to assess in vivo the acceptability of the subjects regarding the same medical device, after 14 days of using the medical device, by selfassessment, filling-in subjective evaluation questions.

NCT ID: NCT06153680 Completed - Quality of Life Clinical Trials

Consumer Study for the Evaluation of the Usability and Efficacy of One Medical Device in Venous Return

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess in vivo the efficacy of the insoles in improving venous return in subjects affected by this problem after 14 days of medical device use, by self-assessment, filling-in questions regarding Quality of Life, in comparison to the baseline. The secondary goals of this study are (1) to assess in vivo the perception of subjects about the rapid relief felt after 7 days of using the same medical device, by self-assessment, filling-in three subjective evaluation questions, and (2) to assess in vivo the usability of the subjects regarding the same medical device after 14 days of its use, by self-assessment, filling-in subjective evaluation questions.

NCT ID: NCT05633277 Recruiting - Clinical trials for Venous Insufficiency

Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections.

NCT ID: NCT05628948 Recruiting - Clinical trials for Cardiovascular Diseases

Vascular Lab Resource (VLR) Biorepository

Start date: November 14, 2019
Phase:
Study type: Observational

This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.

NCT ID: NCT05489588 Recruiting - Venous Leg Ulcer Clinical Trials

The GORE® VIAFORT Vascular Stent Iliofemoral Study

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction.

NCT ID: NCT05409976 Recruiting - Venous Leg Ulcer Clinical Trials

The GORE® VIAFORT Vascular Stent IVC Study

Start date: October 25, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.

NCT ID: NCT05050799 Recruiting - Venous Disease Clinical Trials

US Post-Market Surveillance Study of the Surfacer System

Start date: February 8, 2022
Phase:
Study type: Observational

Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.

NCT ID: NCT04964817 Terminated - Clinical trials for Heart Failure With Preserved Ejection Fraction

HFpEF and Symptomatic Obstructive Iliofemoral Venous Disease Study

PERSUADE
Start date: August 3, 2021
Phase:
Study type: Observational

To ascertain the potential symptom improvement assessed by Cardiopulmonary Exercise Testing (CPET) in subjects with heart failure with preserved ejection fraction (HFpEF) and nonthrombotic iliofemoral venous lesions and/or iliocaval obstruction defined by MR or CT venography AND CEAP Clinical Category ≥3 prior to venous stenting.

NCT ID: NCT04758728 Completed - Venous Reflux Clinical Trials

Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping

ARESQOLSAVES
Start date: September 10, 2015
Phase: N/A
Study type: Interventional

Aim of the present study is to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic.