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Fistula clinical trials

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NCT ID: NCT05906550 Recruiting - Clinical trials for Hemodialysis Access Failure

Flow Dysfunction of Hemodialysis Vascular Access

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

The FLOW trial evaluates the follow-up of the vascular access for hemodialysis. In current clinical care, vascular access flow volume is periodically assessed to detect and treat asymptomatic stenosis. The FLOW trial will determine whether it is safe to abandon this practice of active surveillance. Vascular access stenosis will then be treated only when clinical problems of flow dysfunction occur during hemodialysis. The investigators expect that the intervention rate and medical costs will be reduced by 40% when correction of vascular access stenosis is triggered by clinically apparent access dysfunction rather than asymptomatic flow reduction.

NCT ID: NCT05852457 Recruiting - Fistula Clinical Trials

Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip

Start date: August 31, 2022
Phase:
Study type: Observational

This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed.

NCT ID: NCT05836883 Recruiting - Crohn's Disease Clinical Trials

Study of ExoFlo for the Treatment of Perianal Fistulas

Start date: August 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.

NCT ID: NCT05809258 Recruiting - Clinical trials for Arteriovenous Fistula

Supraclavicular Versus Axillary Block for Arteriovenous (AV) Fistula Creation

CUGSCAB
Start date: August 7, 2023
Phase: N/A
Study type: Interventional

This study compares the analgesic efficacy of supraclavicular brachial plexus nerve block to axillary nerve block techniques in adults undergoing AV fistula creation. Both these techniques will be done under ultrasound guidance, using the same local anesthetic drug. 120 patients will be included in this study, 60 patients for each technique. This study will help us know better regional anesthesia techniques, the additional need for analgesia/anesthesia, and the recovery rate following either of the blocks for AV fistula surgery. An interim analysis will be done after recruiting 50% of cases (30 cases) in both arms.

NCT ID: NCT05805449 Recruiting - Anal Fistula Clinical Trials

BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

BIO RAMP
Start date: February 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

NCT ID: NCT05766566 Recruiting - Crohn Disease Clinical Trials

Treatment of Perianal Fistulas in Crohn's Disease With Autologous Microfragmented Adipose Tissue With the Lipogems System

Start date: March 7, 2023
Phase:
Study type: Observational

The aim of the study is to verify the efficacy of microfragmented autologous adipose tissue with the Lipogems® system, in the treatment of perianal fistulas of m. Crohn's. The Lipogems® International, Milan, Italy, system is a sterile and disposable device that allows to harvest adipose tissue, process it and use it for intraoperative autologous transplantation of human adipose tissue mesenchymal cells that have a gene expression profile and phenotypic similar to that of adipose stem cells. The system consists of a container with metal beads capable of carrying out, by handling, a mechanical micro-fragmentation of the lipoaspirate and of a washing and filtering system which allows to progressively reduce the size of the adipose tissue clusters down to 0.2-0.8 mm and eliminate blood and oily residues. The processed Lipogems® is fluid and easily injectable and is rich in mesenchymal cells and pericytes. The processed Lipogems® will be injected around the fistulous tract and the tissue area closing the internal orifice to promote healing.

NCT ID: NCT05758805 Recruiting - Atrial Fibrillation Clinical Trials

Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)

ESO-SAFE-HP-RF
Start date: January 8, 2024
Phase: N/A
Study type: Interventional

This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are: - Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen. - Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development. - Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.

NCT ID: NCT05757726 Recruiting - Clinical trials for Arteriovenous Fistula

Early Feasibility of the Velocity™ Percutaneous pAVF System

VENOS-1
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.

NCT ID: NCT05753735 Recruiting - Pancreatic Fistula Clinical Trials

eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF

Start date: January 18, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to investigate if prolonged antibiotics after pancreatoduodenectomy can prevent the development of a pancreatic fistula and related complications. Participants who are at high risk of pancreatic fistula will be administered an extended course of antibiotics. While inpatient, the patient will receive these antibiotics through the vein, and after discharge, the antibiotics will be taken by mouth.

NCT ID: NCT05737875 Recruiting - Pancreatic Fistula Clinical Trials

Distal Pancreatectomy Pancreatic Fistula Risk Prediction Model Validation Study

DPFValid
Start date: April 7, 2023
Phase:
Study type: Observational

Distal pancreas resection is a relatively rare procedure with a known risk of postoperative pancreatic fistula. Until quite recently, no valid risk prediction models for this have been available. In 2022 two different risk scores DISPAIR and D-FRS were published. The aim of this study is to compare, validate and possibly improve those scores in a international retrospective multicenter cohort.