A Study of Surgical Interventions in Fistulizing Conditions

Last updated: March 18, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04940611
Alofisel-5007
  • Ages > 18
  • All Genders

Study Summary

In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.

The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants with CPF-CD

  1. CPF-CD that meets one or more of the following criteria:
  • High inter-sphincteric, high trans-sphincteric, extra-sphincteric orsupra-sphincteric fistula, or

  • Presence of greater than or equal to (>=) 2 external openings, or

  • Associated perianal abscess(es)

  1. Physician has made the decision to treat with a specific surgical intervention.Procedures may include:
  • Fistulotomy, fistula plug, fibrin glue, advancement flap (AF), ligation ofinter-sphincteric fistula tract (LIFT), flap repair, fistulectomy, proctectomy,stem cell therapy, other; and seton for palliative purposes.

Participants with CD-RVF: Rectovaginal fistula per physician diagnosis

  1. Physician has made the decision to treat with a specific surgical intervention.Procedures may include:
  • Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy,proctectomy, stem cell therapy, gracilis muscle interposition/tissue grafts, martiusprocedure, abdominal procedures, other; and seton use for palliative purposes.

Participants with CCF:

  1. Complex cryptoglandular fistula that meets one or more of the following criteria:
  • Mid or high trans-sphincteric, or

  • Anterior in women, or

  • Horseshoe fistula

  1. Physician has made the decision to treat with a specific surgical intervention.Procedures may include:
  • Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy,proctectomy, stem cell therapy, other; and seton use for palliative purposes

Exclusion

Exclusion Criteria:

Participants who meet any below mentioned criterion among CPF-CD, CD-RVF, and CCF diagnosis will be excluded from the study.

  1. Current participation in interventional clinical trials.

  2. Has CPF-CD: fistula connection to bladder or another organ

  3. Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including UlcerativeColitis, and Crohn's Disease (CD).

Study Design

Total Participants: 750
Study Start date:
August 05, 2021
Estimated Completion Date:
May 02, 2026

Study Description

This is a non-interventional, prospective study of participants with complex fistulizing conditions (CPF-CD, CD develops CD-RVF and CCF) who are currently undergoing surgical intervention in the real world clinical setting.

The study will enroll approximately 750 participants. The data will be collected prospectively at the study sites and will be recorded into electronic data capture forms (EDCs). Participants will be enrolled to the following observational cohorts:

  • Participants With CPF-CD

  • Participants With CD-RVF

  • Participants With CCF

This multi-center study will be conducted in the United States, Canada, Europe, and Israel. Participants undergoing surgical interventions to treat fistulas will be enrolled from surgical and gastrointestinal (GI) specialty sites. The overall duration of the study will be 24 months. Data will be collected at baseline with follow-up information collected approximately every 3 to 6 months.

Connect with a study center

  • AKH - Medizinische Universitat Wien

    Vienna, 1090
    Austria

    Site Not Available

  • UZ Antwerpen

    Antwerp, 2650
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Jessa Ziekenhuis Hospital

    Hasselt, 3500
    Belgium

    Site Not Available

  • Clinique CHC MontLegia

    Liege, 4000
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • St. Pauls Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91
    Czechia

    Site Not Available

  • NH Hospital a.s.Nemocnice Horovice

    Horovice, 268 31
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Benite, Bouches-du-Rhone 69310
    France

    Site Not Available

  • Fondation Maison Sante Bagatelle

    Talence, Gironde 33400
    France

    Site Not Available

  • CHU de Rennes - Hopital Pontchaillou

    Rennes cedex 09, Ille Et Vilaine 35000
    France

    Site Not Available

  • CHRU Hopital Claude Huriez

    Lille, Nord 59037
    France

    Site Not Available

  • CHU de Rouen - Hopital Charles Nicolle

    Rouen Cedex, Seine Maritime 76031
    France

    Site Not Available

  • Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon

    Paris, 75012
    France

    Site Not Available

  • Hopital Saint Joseph - Paris

    Paris, 75014
    France

    Site Not Available

  • Shamir Medical Center (Assaf Harofeh)

    Be'er Ya'aqov, 7033001
    Israel

    Site Not Available

  • Rambam Health Care Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Wolfson Medical Center

    Holon, 58100
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht, 3508 GA
    Netherlands

    Site Not Available

  • Broomfield Hospital

    Chelmsford, Essex CM1 7ET
    United Kingdom

    Site Not Available

  • Nottingham University Hospital

    Nottingham, Nottinghamshire NG7 2UH
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary.

    Newcastle upon Tyne, Tyne & Wear NE1 4LP
    United Kingdom

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • University of South Florida - PARENT

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • GI Alliance - Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Lenox Hill Hospital PRIME

    New York, New York 10075
    United States

    Site Not Available

  • UNC Hospitals

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Premier Health

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Penn Medicine PA

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Vanderbilt University Medical Center- GI Endoscopy Lab

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Baylor Research Institute

    Dallas, Texas 75204
    United States

    Site Not Available

  • Colon & Rectal Clinic

    Houston, Texas 77030
    United States

    Site Not Available

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