Clinical trials: Fistula
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.
- Trial name
- NCT02119845
- Testing
- Endovascular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 16 people
- Sponsor
- C. R. Bard
Anal Fistula
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Primary outcome variable is healing at the final follow up visit.
- Trial name
- NCT01290666
- Testing
- Fistula Plug
- Volunteers
- 93 people
- Sponsor
- W.L.Gore & Associates
Larynx Cancer, Pharynx Cancer
Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.
- Conditions
- Larynx Cancer, Pharynx Cancer, Pharyngocutaneous Fistula
- Trial name
- NCT03479463
- Testing
- Dehydrated human amnion/chorion membrane
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- MiMedx Group, Inc.
Arteriovenous Fistula
Paclitaxel-Coated Balloon for the Treatment of AVF
To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the…
- Trial name
- AVF (NCT05088083)
- Testing
- Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
- Volunteers
- 143 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Arteriovenous Fistula Stenosis
Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
- Trial name
- NCT07452822
- Testing
- Human umbilical cord mesenchymal stem cells injection, saline solution
- Volunteers
- 54 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Arteriovenous Fistula, Arteriovenous Fistula Stenosis
IN.PACT™ AV Access Post-Approval Study (PAS002)
Long-term safety will be summarized
- Conditions
- Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Fistula
- Trial name
- NCT04543539
- Testing
- IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort, IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
- Where
- 20 sites in United States
- Volunteers
- 240 people
- Sponsor
- Medtronic
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
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.
Peripheral Artery Disease, Arteriovenous Fistula Stenosis
FLEX Arteriovenous Access Registry
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
- Conditions
- Peripheral Artery Disease, Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis
- Trial name
- NCT04070365
- Testing
- FLEX Vessel Prep System followed by angioplasty
- Where
- 10 sites in United States
- Volunteers
- 114 people
- Sponsor
- VentureMed Group Inc.
Perianal Fistula, Crohn's Disease
A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease
- Trial name
- NCT05626023
- Testing
- Human TH-SC01 cell injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Nasal Polyps
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps.
- Trial name
- NCT00731185
- Testing
- Mometasone Furoate Nasal Spray
- Volunteers
- 162 people
- Sponsor
- Organon and Co
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
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
End-stage Renal Disease
Ellipsys Vascular Access System Registry
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a…
- Trial name
- NCT03454113
- Testing
- Ellipsys Vascular Access
- Where
- 5 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Medtronic Endovascular
Intracranial Aneurysm, AVM - Cerebral Arteriovenous Malformation
Postmarket Study of Tarvos Microguidewire in Neurovascular Interventional Surgery
This investigation is to evaluate the clinical effectiveness and safety of the Tarvos Microguidewire in the neurovascular interventional surgery.
- Conditions
- Intracranial Aneurysm, AVM - Cerebral Arteriovenous Malformation, AV Fistula, Acute Ischemic Stroke
- Trial name
- NCT07500155
- Testing
- Tarvos Microguidewire
- Where
- China
- Volunteers
- 121 people
- Sponsor
- Keuro MedTech
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
Perianal Fistula, Crohn's Disease
Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional…
- Trial name
- NCT04847739
- Testing
- Seton Placement, AVB-114
- Where
- 15 sites in United States
- Volunteers
- 60 people
- Sponsor
- Avobis Bio, LLC
Perianal Fistula Due to Crohn's Disease
Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection
The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because…
- Trial name
- EAP-STOMP2 (NCT06509828)
- Testing
- AVB-114
- Sponsor
- Avobis Bio, LLC
Crohn's Disease, Fistula
Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula
This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.
- Trial name
- ANTG-ASC-203 (NCT01314079)
- Where
- 3 sites in South Korea
- Volunteers
- 37 people
- Sponsor
- Anterogen Co., Ltd.
Needle Phobia, Phobic Disorders
Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted.
- Trial name
- NCT01623583
- Testing
- Enhanced Needle Phobia Intervention, Standard Needle Phobia Intervention
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Davita Clinical Research