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Fistula clinical trials

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NCT ID: NCT04075825 Completed - Crohn's Disease Clinical Trials

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Start date: November 4, 2019
Phase: Phase 3
Study type: Interventional

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

NCT ID: NCT04073472 Withdrawn - Crohn's Disease Clinical Trials

Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's

IPAAF
Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with an ileal pouch anal anastomosis (IPAA) who develop a fistula in the setting of Crohn's disease of the pouch.

NCT ID: NCT04070365 Completed - Clinical trials for Peripheral Artery Disease

FLEX Arteriovenous Access Registry

Start date: May 28, 2018
Phase:
Study type: Observational [Patient Registry]

Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.

NCT ID: NCT04069728 Completed - Fistula in Ano Clinical Trials

The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making

3DAF
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

An anal fistula is an abnormal communication between the luminal surface of the anorectal canal and the perianal skin. Fistulas can vary in their complexity and can be challenging to treat, due to the anatomical relation to the anal sphincter complex that controls continence. In addition, fistulas can display complex features such as branches, cavities and horseshoes; where the tract travels radially around the anal canal. All these features have a role in determining the most appropriate surgical treatment option, and are key to understanding the surgical decision-making process. This study will determine patient understanding of fistula anatomy, their perception of their own understanding, their rating of how good their clinician's explanation is and how this impacts the decision-making process using standard explanation with 2D images, versus a 3D printed model of a fistula.

NCT ID: NCT04058236 Recruiting - Pancreatic Cancer Clinical Trials

Glycocalyx Levels in Patients Undergoing Pancreatectomy

Start date: August 15, 2019
Phase: Phase 4
Study type: Interventional

Background: On the surface of every healthy cellular membrane resides a layer known as the glycocalyx. This structure consists of extracellular domains of receptor, adhesion and transmembrane molecules such as syndecan-1 covalently bound to highly negatively charged glycosaminoglycans, heparan sulfates. It has a principal role to maintain wall integrity, avoid inflammation and tissue oedema in vessels but in contrast, glycocalyx is robust and elevated on cancer cells. This study examines whether the endothelial glycocalyx layer is preserved in patients undergoing pancreatectomy with human albumin 5% vs. gelofusine in a restrictive goal directed fluid regime perioperatively for the first 24hours. Degradation of glycocalyx will be investigated by analyzing basic levels of the core protein syndecan-1 and heparan sulfates with post-operative samples.

NCT ID: NCT04054440 Enrolling by invitation - Clinical trials for Peripheral Arterial Disease

Outpatient Office Based Endovascular Procedures

Start date: June 20, 2014
Phase:
Study type: Observational

The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite. Additionally, other studies could compare clinical outcomes between procedures performed in an office based angiosuite and other settings.

NCT ID: NCT04049955 Completed - Gastrostomy Clinical Trials

Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique

bartoli
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Obesity is a major health problem in western countries, and sleeve gastrectomy has proven its effectiveness on weight loss and improvement of comorbidities related to obesity. The main complication is the occurrence of upper fistula (2%), and may be responsible of several deaths. There is no consensus on medical, radiological and surgical management of fistula. It depends on the resources of each center and is based on a low level evidence The inconstant efficacy of the endoscopic treatment by closing fistula (digestive stents, clips, glue) motivates a new endoscopic approach. It consists of an internal drainage of the collection by using double pigtail stents through the fistulous orifice.

NCT ID: NCT04034433 Recruiting - Clinical trials for Arteriovenous Fistula

Exercise Program for Arteriovenous Fistula Maturation

FAVULOUS
Start date: October 4, 2019
Phase: N/A
Study type: Interventional

Arteriovenous fistula (AVF) is the recommended vascular access for chronic hemodialysis, as it is associated with less mortality and better patency than arteriovenous graft (AVG) or central venous catheter (CVC). Unfortunately, AVF suffers from a high failure rate, due, in part, to poor venous diameter. The aim of this study is to investigate whether a perioperative handgrip training can improve the diameter of AVF in patients with chronic kidney disease (CKD) (stage IV-V).

NCT ID: NCT04017910 Terminated - Clinical trials for Arteriovenous Fistula

Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

Start date: December 2, 2019
Phase:
Study type: Observational

This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.

NCT ID: NCT04017806 Recruiting - Clinical trials for Arteriovenous Fistula

Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation

Start date: September 19, 2018
Phase:
Study type: Observational

Introduction Arteriovenous fistula (AVF) is the preferred hemodialysis vascular access due to its higher patency and lower infection rate. However, its major weakness is suboptimal maturation rate. Although that substantial risk factors for AVF maturation failure have been disclosed, a modifiable risk factor remains absent. While contemporary theory for AVF maturation failure focuses on disturbed wall shear stress, complicate assumtions and measurement preclude its clinical applicability. In the process of AVF maturation, elevated luminal pressure is required for outward remodeling, however, exccessively high luminal pressure may also be ditremental to AVF maturation, which remains to be defined. This study hypothesize that higher AVF luminal pressure is harmful to its maturation and investigate its potential as a modifiable factor to improve AVF maturation. Methods and analysis This prospective study includes patients receiving surgical creation of native AVF. The exclusion criteria include age <20 years, inability to sign inform consent and failure to create native AVF deu to technical difficulty. Demographic and labboratory profile will be collected before AVF surgery. Vascular sonography will be performed within 1 week of AVF creation to measure the blood flow rates and diameters of AVF and its branched veins. The pressure gredient within AVF will be estimated from blood flow rates by Modified Bernoulli Equation. The primary outcome was spontaneous AVF maturation defined as provision of sufficient blood flow for hemodialysis within 2 months of its creation without any interventional procedures. The secondary outcome is assisted AVF mature, which is defined as AVF maturation within 2 months from its creation, which is aided by any interventional procedure before successful use of AVF. Ethics and dissemination This study has been approved by the ethics committee and Institutional Review Board of Taipei Medical University. Strengths and limitations 1. The strength of the present study is the prospective design that allows complete collection of parameters and outcomes. 2. The predictor of interest for AVF maturation is luminal pressure of AVF. 3. The study assesses hemodynamic parameters of AVF and its branched veins, including diameters, flow rates, and flow volume. 4. The luminal pressure of AVF will be estimated using Modified Bernoulli Equation. 5. The primary outcome of the study is spontaneous AVF maturation.