Clinical trials: Anal Fistula
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
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
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
Phase 3 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 efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.
- Trial name
- NCT06925594
- Testing
- Human TH-SC01 cell injection, Saline solution
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Anal Fistula
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive…
- Trial name
- NCT00115466
- Testing
- Non-surgical autologous implant of ASCs
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Cellerix
Anal Fistula, Complex Perianal Fistulas
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
- Conditions
- Anal Fistula, Complex Perianal Fistulas, Crohn's Disease
- Trial name
- NCT06429241
- Testing
- Mesenchymal Stem Cells (MSCs)
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Anal Fistula
Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia
The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.
- Trial name
- SurgiSIS AFP (NCT00703131)
- Testing
- Anal Fistula Plug (SurgiSIS AFP)
- Where
- Saudi Arabia
- Volunteers
- 35 people
- Sponsor
- Cook Group Incorporated
Anal Fistula
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT…
- Trial name
- LIFT+Graft (NCT01602081)
- Testing
- reinforce soft tissue
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Cook Group Incorporated
Perianal Fistula Due to Crohn's Disease, Fistula in Ano
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic…
- Trial name
- NCT05039411
- Testing
- PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
- Where
- Malaysia
- Volunteers
- 5 people
- Sponsor
- CryoCord Sdn Bhd
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.
Anal Fistulas, Rectal Fistulas
A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas
The study is designed as a prospective, non-randomized clinical trial comparing safety and effectiveness of the CuraSeal PICS-AF device to historical data from commercially available devices for the treatment of anorectal…
- Trial name
- NCT02456324
- Testing
- PICS-AF Device, Historical Controls Treated with Commercially Available Fistula Plugs
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Curaseal Inc.
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
Crohn's Disease, Anal Fistula
Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.
The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.
- Trial name
- NCT01372969
- Testing
- Cx601
- Where
- 6 sites in Spain
- Volunteers
- 24 people
- Sponsor
- Tigenix S.A.U.
Anorectal Fistulas
A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
This will be a prospective, multi-center, post-market, single arm observational study to collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of anorectal fistulas.
- Trial name
- NCT01624350
- Testing
- Permacol collagen paste
- Where
- 10 sites in Denmark, Italy and 1 more
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
Anal Fistula
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.
- Trial name
- NCT05638139
- Testing
- SygeLIX-F + SygeLIX-G
- Where
- 2 sites in France
- Volunteers
- 9 people
- Sponsor
- TBF Genie Tissulaire
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
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
Myriad™ Augmented Soft Tissue Reconstruction Registry
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures.
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus
- Trial name
- MASTRR (NCT05243966)
- Testing
- Myriad Matrix™ and Myriad Morcells™
- Where
- 15 sites in United States
- Volunteers
- 800 people
- Sponsor
- Aroa Biosurgery Limited
Anal Fistula
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to…
- Trial name
- RADIOFIST (NCT03131297)
- Testing
- treatment by radiofrequency
- Where
- 4 sites in France
- Volunteers
- 50 people
- Sponsor
- F Care Systems NV
Anal Fistula
A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas
The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas.
- Trial name
- NCT05641844
- Testing
- RD2 Ver.02, Saline
- Where
- 10 sites in United States, Israel
- Volunteers
- 110 people
- Sponsor
- RedDress Ltd.
Anal Fistula
Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease
Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas.
- Trial name
- FATT1 (NCT00475410)
- Testing
- ASCs (Cx401, company code), Fibrin adhesive
- Where
- 10 sites in Germany, Spain and 1 more
- Volunteers
- 214 people
- Sponsor
- Tigenix S.A.U.