Clinical trials: Fistula, open to volunteers
Stenosis of Native Hemodialysis Arteriovenous Fistulas
ACOART AVF RENEW: A Post Market Clinical Study
The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in…
- Trial name
- NCT06205576
- Testing
- DCB catheter
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Acotec Scientific Co., Ltd
Kidney Disease, End-Stage
PATH-03 Paraguay Feasibility Study
The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
- Trial name
- NCT07034092
- Testing
- ePATH System will be used to create an endoAVF
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Pathfinder Medical
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
Air Leak From Lung, Pneumothorax
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks.
- Trial name
- NCT06548386
- Testing
- Pleural gas analysis
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Lung Healing Technologies Inc
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
- Trial name
- ULTRAVIOLETFIM (NCT07330817)
- Testing
- PTA balloon
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Cardionovum GmbH
ENT Disorder, Nasal Procedures
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or…
- Conditions
- ENT Disorder, Nasal Procedures, Nasal Anesthesia, Nasal Mucosa Surgery
- Trial name
- NCT04792034
- Testing
- Cocaine Hydrochloride Nasal Solution
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- LXO Ireland
Arteriovenous Fistula Stenosis
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous…
- Trial name
- SCDB (NCT06422845)
- Testing
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Where
- 33 sites in China
- Volunteers
- 328 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Arterial Bleed, Pulmonary Arteriovenous Malformation
Okami Medical ALPHA Registry
This registry will provide insights into the use of Okami Medical devices in real-world clinical and study effectiveness and safety of Okami Medical devices.
- Conditions
- Arterial Bleed, Pulmonary Arteriovenous Malformation, Embolization, Hemorrhage
- Trial name
- NCT07525518
- Testing
- LOBO Vascular Occlusion System
- Where
- 6 sites in United States
- Volunteers
- 500 people
- Sponsor
- Okami Medical, Inc.
Chronic Kidney Disease, Hemodialysis Access
Pivotal Study of the Velocity™ pAVF System
This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access.
- Conditions
- Chronic Kidney Disease, Hemodialysis Access, Arteriovenous Fistula, End Stage Renal Disease (ESRD)
- Trial name
- VENOS-3 (NCT07153939)
- Testing
- Velocity Percutaneous Arteriovenous Fistula
- Where
- 13 sites in United States
- Volunteers
- 126 people
- Sponsor
- Venova Medical
Perianal Fistula Due to Crohn's Disease
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing…
- Trial name
- NCT06918808
- Testing
- DB-3Q
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Direct Biologics, LLC
Peripheral Arterial Hemorrhage, Arteriovenous Malformation
The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature
Evaluation of the Safety and Effectiveness of the Peripheral Embolization Coil System Manufactured by Suzhou Zhongtian Medical Instruments Co., Ltd.
- Conditions
- Peripheral Arterial Hemorrhage, Arteriovenous Malformation, Arteriovenous Fistula, Peripheral Aneurysm
- Trial name
- NCT07156409
- Testing
- Peripheral Embolization Coil System
- Volunteers
- 139 people
- Sponsor
- Suzhou Zenith Vascular SciTech Limited
Fistula-in-ano
BioHealx® Anal Fistula Device Post Market Surveillance Study
This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula…
- Trial name
- NCT07021742
- Testing
- BioHealx
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Signum Surgical USA Inc.
Kidney Disease, End-Stage, End-stage Renal Disease
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
- Conditions
- Kidney Disease, End-Stage, End-stage Renal Disease, Arteriovenous Fistula
- Trial name
- CONNECT-AV (NCT04634916)
- Testing
- EndoAVF Creation
- Where
- 17 sites in United States, Australia
- Volunteers
- 220 people
- Sponsor
- C. R. Bard
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
Peripheral Artery Disease (PAD), Dysfunctional AV Fistula
Serranator POINT FORCE Registry
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or…
- Conditions
- Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft
- Trial name
- POINT FORCE (NCT06687590)
- Testing
- Peripheral balloon angioplasty
- Where
- 19 sites in United States
- Volunteers
- 500 people
- Sponsor
- Cagent Vascular LLC
Diabetes, End Stage Renal Disease
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula…
- Trial name
- MAFASA (NCT06190717)
- Testing
- EchoMark/EchoSure, Standard of Care
- Where
- 23 sites in United States
- Volunteers
- 304 people
- Sponsor
- Sonavex, Inc.
Chronic Kidney Diseases, End Stage Renal Disease
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a…
- Conditions
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure
- Trial name
- SAVE-FistulaS (NCT06001827)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control
- Where
- 28 sites in United States
- Volunteers
- 600 people
- Sponsor
- VenoStent
Complex Anal Fistulas
Fistura® Procedure for the Treatment of Complex Anal Fistulas
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
- Trial name
- NCT06113068
- Testing
- Fistura® procedure
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- F Care Systems NV
Crohn's Disease
A Survey of Darvadstrocel in People With Crohn's Disease
This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide…
- Trial name
- J-INSPIRE (NCT05113095)
- Testing
- Darvadstrocel
- Where
- Japan
- Volunteers
- 275 people
- Sponsor
- Takeda
Venous Stenosis, Venous Occlusion
WRAP North America
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population.
- Trial name
- NCT06807099
- Testing
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
- Where
- 16 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Merit Medical Systems, Inc.