Clinical trials: Fistula
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
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- Okami Medical, Inc.
Vesico-vaginal Fistula
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.
- Trial name
- VVP (NCT00923338)
- Testing
- Surgisis Biodesign (Vesico-vaginal fistula plug)
- Where
- Uganda
- Volunteers
- 20 people
- Sponsor
- Cook Group Incorporated
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
Peripheral Arterial Disease, Fistula
A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in…
- Trial name
- NCT02962141
- Testing
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Balloon Dilatation Catheter
- Where
- 9 sites in China
- Volunteers
- 161 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Arterio-Venous Fistula, ESRD
VasQ External Support for Arteriovenous Fistula
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing…
- Conditions
- Arterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm
- Trial name
- NCT03242343
- Testing
- VasQ
- Where
- 15 sites in United States
- Volunteers
- 144 people
- Sponsor
- Laminate Medical Technologies
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive…
- Trial name
- NCT03124875
- Testing
- LimFlow System
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- LimFlow, Inc.
Anorectal Fistula
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for…
- Trial name
- NCT03321266
- Testing
- Cook Biodesign® Fistula Plug
- Where
- 4 sites in United States, Germany
- Volunteers
- 79 people
- Sponsor
- Cook Group Incorporated
Complex Perianal Fistula, Crohn Disease
Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease
The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem cells) for treatment of complex perianal fistulas in patients with Crohn's disease.
- Trial name
- FATT (NCT01378390)
- Testing
- Expanded autologous adipose-derived adult stem cells (eASCs)
- Where
- 12 sites in Austria, Netherlands and 1 more
- Volunteers
- 56 people
- Sponsor
- Tigenix S.A.U.
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
Aneurysm, Arteriovenous Malformations
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
- Conditions
- Aneurysm, Arteriovenous Malformations, Arterio-venous Fistula
- Trial name
- NCT03853070
- Testing
- ED Coil / Electro-detach Generator v4
- Where
- 3 sites in Belgium, Germany
- Volunteers
- 100 people
- Sponsor
- Kaneka Corporation
Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion
IN.PACT™ AV Access IDE Study
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic…
- Conditions
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula, Fistula
- Trial name
- NCT03041467
- Testing
- IN.PACT AV DCB, Standard Balloon Angioplasty
- Where
- 29 sites in United States, Japan and 1 more
- Volunteers
- 330 people
- Sponsor
- Medtronic Endovascular
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
End Stage Renal Failure on Dialysis
Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
The purpose of the investigation is to confirm the safety and performance of the Argyle™ Safety Fistula Cannula with Anti-reflux Valve for hemodialysis treatment.
- Trial name
- NCT05927532
- Testing
- Argyle Safety Fistula Cannula with Anti-Reflux Valve
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Mozarc Medical US LLC
Perianal Fistula, Crohn's Disease
Study of ExoFlo for the Treatment of Perianal Fistulas
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.
- Trial name
- NCT05836883
- Testing
- ExoFlo, Local injection of normal saline
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Direct Biologics, LLC
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
Arteriovenous Fistula
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.
- Trial name
- AVR (NCT02746159)
- Testing
- Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 320 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.
Inflammatory Bowel Disease, Intestinal Fistula
Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas.
- Trial name
- NCT00321412
- Testing
- AST-120
- Where
- 88 sites in United States, Austria and 10 more
- Volunteers
- 191 people
- Sponsor
- Ocera Therapeutics
Crohn's Disease, Complex Perianal Fistula
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
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.
- Trial name
- NCT04075825
- Testing
- Darvadstrocel
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 150 people
- Sponsor
- Takeda
Chronic Kidney Disease
Novel Endovascular Access Trial (NEAT)
The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require…
- Trial name
- NEAT (NCT02036671)
- Testing
- The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
- Where
- 9 sites in Australia, Canada and 1 more
- Volunteers
- 80 people
- Sponsor
- C. R. Bard