Clinical trials: Fistula
End Stage Renal Disease, AV Fistula
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
- Conditions
- End Stage Renal Disease, AV Fistula, Kidney Failure
- Trial name
- SAVE (NCT01471041)
- Testing
- Venous Window Needle Guide
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Vital Access Corp.
Arteriovenous Fistula, Hemodialysis
Arteriovenous Fistula Cannulation Practices and Dialysis Adequacy
Arteriovenous fistulae are preferred among methods of providing blood access for hemodialysis. For each hemodialysis treatment, the fistula is cannulated usually with two needles.
- Conditions
- Arteriovenous Fistula, Hemodialysis, Dialysis Adequacy
- Trial name
- NCT04270292
- Where
- Turkey (Türkiye)
- Volunteers
- 164 people
- Sponsor
- Istanbul Demiroglu Bilim University
AV Fistula
Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access
The Objectives of this study are: 1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo. 2.
- Trial name
- NCT02475837
- Testing
- Vorapaxar sulfate
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Ken Mahaffey
Female Genital Fistula, Urinary Incontinence
Fistula Reintegration Pilot
This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling…
- Trial name
- NCT04748653
- Testing
- Multi-component reintegration intervention
- Where
- Uganda
- Volunteers
- 12 people
- Sponsor
- University of California, San Francisco
Pancreatic Leak, Pancreatic Fistula
A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
This is a single arm investigator-initiated study designed to test the feasibility and potential efficacy of preoperative lanreotide to reduce the risk of postoperative abscess or pancreatic leak and fistula.
- Conditions
- Pancreatic Leak, Pancreatic Fistula, Pancreaticoduodenal; Fistula, Pancreatectomy; Hyperglycemia
- Trial name
- NCT03174353
- Testing
- Lanreotide Prefilled Syringe
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- University of Washington
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
Venous Stenosis, Venous Occlusion
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
- Trial name
- WAVE (NCT04540302)
- Testing
- Merit WRAPSODY Endovascular Stent Graft, PTA
- Where
- 43 sites in United States, Brazil and 2 more
- Volunteers
- 357 people
- Sponsor
- Merit Medical Systems, Inc.
Pancreatic Fistulae
Stereotactic Radiation to Decrease Pancreatic Secretions
Patients that have undergone pre-operative radiation for pancreatic carcinoma, that upon pathologic examination of the normal portion of the pancreatic gland that was in the radiation field showed acute and chronic changes in the…
- Trial name
- NCT01656486
- Testing
- Stereotactic Radiation
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Wake Forest University Health Sciences
Arteriovenous Fistula, Arteriovenous Graft
Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
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.
- Trial name
- NCT04017910
- Testing
- EchoMark/EchoSure
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Sonavex, Inc.
Hidradenitis Suppurativa
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.
- Trial name
- NCT02805595
- Testing
- 23.4% Hypertonic saline
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Beth Israel Deaconess Medical Center
Kidney Diseases, Arteriovenous Fistula
Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.
- Trial name
- NCT04896476
- Testing
- EchoMark / EchoSure
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sonavex, Inc.
Esophageal Fistula, Esophageal Neoplasms
Removal of the Evolution® Esophageal Stent - Fully Covered
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
- Conditions
- Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis
- Trial name
- CLARITY (NCT01900691)
- Testing
- Evolution® Esophageal Stent - Fully Covered
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- Cook Group Incorporated
Osteoradionecrosis
Management of Mandibular ORN: PENTO as Medical Treatment
Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.
- Trial name
- PENTO (NCT02368457)
- Testing
- Pentoxifylline and Tocopherol
- Where
- Spain
- Volunteers
- 24 people
- Sponsor
- Hospital Vall d'Hebron
End Stage Renal Disease, AV Fistula
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Trial name
- NCT02363972
- Testing
- Ellipsys Vascular Access Catheter
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- Medtronic Endovascular
Anal Fistula, Crohn's Disease
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft
Healing anal fistulas in Crohn's patients with an anal fistula plug.
- Trial name
- SurgiSIS AFP (NCT00610207)
- Testing
- Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Cook Group Incorporated
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.
Inflammatory Bowel Disease, Perianal Fistula
Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Perianal Abscess
- Trial name
- NCT00972088
- Testing
- capsule endoscopy
- Where
- 3 sites in Israel
- Volunteers
- 26 people
- Sponsor
- Bikkur Holim Hospital
Hernia, Ventral, Intestinal Fistula
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix).
- Conditions
- Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal
- Trial name
- NCT02228889
- Testing
- Abdominal wall reconstruction with Strattice, Assess pain intensity at last office visit preoperatively, Assess pain interference at last office visit preoperatively
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Jeffrey Janis
Anal Fistula
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
- Trial name
- Surgisis® AFP (NCT00545441)
- Testing
- Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP), Flap
- Where
- 6 sites in Germany
- Volunteers
- 86 people
- Sponsor
- Cook Group Incorporated
Complex Perianal Fistulas in Adult Participants With Crohn's Disease
Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease
The purpose of this study is to evaluate the efficacy of darvadstrocel for the treatment of complex perianal fistulas in adult participants with Crohn's disease over 24 weeks.
- Trial name
- NCT03706456
- Testing
- Darvadstrocel
- Where
- 11 sites in Japan
- Volunteers
- 22 people
- Sponsor
- Takeda