Clinical trials: Fistula-in-Ano
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 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
Crohn Disease (CD)
Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study. Its design is supported by the following elements: The results of the ADICROHN pilot study (EudraCT No.
- Trial name
- ADICROHN3 (NCT07629245)
- Testing
- injection of thawed SVF
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
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, Fistula in Ano
Impact of Preoperative Bowel Preparation on Healing Outcomes in FiLaC
Background: Fistula tract laser closure (FiLaC) has emerged as a sphincter-preserving treatment for anal fistula (AF). However, the optimal role of preoperative bowel preparation (BP) in enhancing postoperative outcomes remains…
- Conditions
- Anal Fistula, Fistula in Ano, Laser, Anal Fistula Surgery
- Trial name
- FiLaC-PREP (NCT07800065)
- Testing
- Bowel preparation before fistula laser closure (FiLaC) surgery
- Volunteers
- 100 people
- Sponsor
- Acibadem Kent Hospital
Complex Anal Fistula
LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas
Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders.
- Trial name
- NCT05201209
- Where
- France
- Volunteers
- 110 people
- Sponsor
- Fondation Hôpital Saint-Joseph
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.
Quality of Life, Anal Fistula
Changes in Patients' Quality of Life With Differences in Seton Application
Investigators aim to investigate the changes in patients' quality of life with different type of seton application.
- Trial name
- NCT05348473
- Testing
- Alpha type, Beta type, Comfort type
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Ankara University
Anal Fistula Surgery, Anal Fistula
Impact of Surgical Timing on Anal Fistula Outcomes
This study aims to evaluate if the amount of time a person experiences symptoms of an anal fistula before having surgery affects their surgical outcomes and recovery.
- Conditions
- Anal Fistula Surgery, Anal Fistula, Surgery Timing
- Trial name
- NCT07482241
- Volunteers
- 90 people
- Sponsor
- Assiut University
Anal Fistula, Minimal Invasive Surgery
Treatment of Anal Fistulas With Obsidian RFT®
The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.
- Conditions
- Anal Fistula, Minimal Invasive Surgery, Platelet-rich Fibrin Foam
- Trial name
- NCT06136325
- Testing
- Obsidian RFP anal fistula surgery
- Where
- Austria
- Volunteers
- 18 people
- Sponsor
- Medical University of Vienna
Hemorrhoids, Fissure in Ano
Pre-Emptive Analgesia in Ano-Rectal Surgery
The perianal region is the region around the anus. Administering a pain medication before a surgery starts is called preemptive analgesia.
- Conditions
- Hemorrhoids, Fissure in Ano, Rectal Fistula, Anal Condyloma
- Trial name
- PEAARS (NCT02402543)
- Testing
- Gabapentin, Ketamine, Acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- University of Vermont
Fissure;Anal, Fistula;Rectal
Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery
Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac, referred as treatment B) in benign anorectal…
- Conditions
- Fissure;Anal, Fistula;Rectal, Hemorrhoids
- Trial name
- NCT02961855
- Testing
- anesthesics plus antiinflammatory, CLIFE1, local anesthesics, CLIFE2
- Volunteers
- 120 people
- Sponsor
- Hospital de Viladecans
Fistula in Ano, Rectal Fistula
Laser Assisted Treatment of Fistula In Ano
Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.
- Trial name
- LATFIA (NCT05390151)
- Testing
- Laser treatment of anal fistula, RAF
- Where
- 5 sites in Belgium
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Crohn's Disease, Peri-anal Fistulas
Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas
Objective: The aim of this study is to investigate whether Crohn's Disease patients with peri-anal fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's Disease patients that would benefit from…
- Conditions
- Crohn's Disease, Peri-anal Fistulas, Sexual Dysfunction
- Trial name
- NCT01635543
- Where
- Canada
- Sponsor
- University of British Columbia
Perianal Fistula
This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High Perianal Fistula Treatment. The Study Aims to Determine Whether the GLUBRAN®-Coated Seton Improves Healing, Reduces Postoperative Pain and Recurrence, and Better Preserves Anal Continence.
High anal fistula is a complex anorectal condition that can cause persistent pain, purulent discharge, recurrent infection, and a significant reduction in quality of life.
- Trial name
- NCT07676825
- Testing
- Glubran-coated Seton, Seton
- Where
- Egypt
- Volunteers
- 36 people
- Sponsor
- Kasr El Aini Hospital
High Anal Fistula
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula
The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.
- Trial name
- NCT04796376
- Testing
- combined partial fistulectomy or fistulotomy and cutting seton procedure
- Where
- Egypt
- Volunteers
- 25 people
- Sponsor
- Assiut University
Perianal Abscess, Anal Fistulas
Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife.
- Conditions
- Perianal Abscess, Anal Fistulas, Incontinence
- Trial name
- NCT02306382
- Testing
- Perianal abscess drainage, 3D ultrasonography
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- University Hospital, Umeå
Anal Fistula
"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"
Background: Complex perianal fistulas pose a challenge to surgeons since the fistulous tract must be eliminated without impairing continence.
- Trial name
- NCT04740086
- Testing
- Calcium alginate hydrogel
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Anal Fistula
RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton
LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane.
- Trial name
- NCT04377542
- Testing
- LIFT, Parks, Seton
- Where
- Egypt
- Volunteers
- 66 people
- Sponsor
- Mansoura University