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Anal Fistula clinical trials

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NCT ID: NCT06429241 Recruiting - Crohn's Disease Clinical Trials

Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

Start date: April 8, 2024
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT06184438 Recruiting - Anal Fistula Clinical Trials

Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery

Start date: December 13, 2023
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.

NCT ID: NCT05805449 Recruiting - Anal Fistula Clinical Trials

BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

BIO RAMP
Start date: February 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

NCT ID: NCT05641844 Recruiting - Anal Fistula Clinical Trials

A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

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. The main questions it aims to answer are: Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compared to control. Complication rate by 6 months of anal fistula treatment with RD2 Ver.02 compared to control. Recurrence of anal fistula at 12 months post-treatment Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. Patients will be randomized in to 2 arms. For all patients, blood will be drawn to ensure the blinding of the patients, the fistula will be evaluated and debrided, and then the internal fistula opening will be suture-closed, and a water leak test will be performed to ensure sealing. Following the water leak test, In the treatment arm, the patient's own coagulating blood will be applied into the entire fistula tract, allowing it to clot and serve as a provisional matrix inside the fistula tract. In the control arm, the blood sample will be discarded and saline will be applied to the fistula tract.

NCT ID: NCT05638139 Recruiting - Anal Fistula Clinical Trials

Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly

Start date: June 27, 2023
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT05348473 Recruiting - Quality of Life Clinical Trials

Changes in Patients' Quality of Life With Differences in Seton Application

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

Investigators aim to investigate the changes in patients' quality of life with different type of seton application.

NCT ID: NCT05243966 Recruiting - Clinical trials for Hidradenitis Suppurativa

Myriad™ Augmented Soft Tissue Reconstruction Registry

MASTRR
Start date: January 10, 2022
Phase:
Study type: Observational [Patient Registry]

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

NCT ID: NCT05044182 Recruiting - Anal Fistula Clinical Trials

Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

DADS
Start date: October 8, 2021
Phase: N/A
Study type: Interventional

Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.

NCT ID: NCT04790123 Recruiting - Anal Fistula Clinical Trials

Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula

AdiTiF
Start date: October 14, 2020
Phase: N/A
Study type: Interventional

The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Its treatment remains a real challenge due to the limited efficacy of sphincter preservation techniques and the inevitable risk of faecal incontinence in those cases that require surgery. Goals: To evaluate the efficacy and safety of the injection of freshly collected autologous adipose tissue as a minimally invasive, highly reproducible alternative, without risk for the continence of the patient, and of very low cost, in the treatment of complex cryptoglandular anal fistula. Methodology: Prospective multicenter, randomized, double-blinded, parallel-group, placebo-controlled clinical trial. Randomization list for each center to ensure the balance of inter-center allocation. Patients older than 18 years with cryptoglandular anal fistula with suppuration for more than 6 weeks and less than 1 year, who have received at most: curettage and drainage placement will be included. Treatment group: injection of fresh autologous fat into the fistulous tract, after curettage and closure of the internal orifice, and after lipoaspirate fat in the abdomen and centrifugation thereof. Placebo group: curettage and closure of the internal orifice and simulated intervention in the abdomen. Evaluation: protocolized clinical history and fistula complexity score (CFS), subjective perception of its pathology, St.Marks continence score, Quality of life questionnaire (QoLAF), and endoanal 3D ultrasound, at baseline, at one week, and at 3, 6 and 12 months after the intervention. The patients and the evaluator will be blind to the treatment. Patients who cannot end up receiving treatment due to intraoperative incidents or medical decision will be excluded from the study (post randomization exclusion). In each center there will be a blind evaluator to perform the follow-ups and endoanal ultrasound.

NCT ID: NCT04750499 Recruiting - Anal Fistula Clinical Trials

Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection

Fistula_CM1
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease.