A Study of Surgical Interventions in Fistulizing Conditions

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 or supra-sphincteric fistula, or.
  • - Presence of greater than or equal to (>=) 2 external openings, or.
  • - Associated perianal abscess(es) 2.
Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
  • - Fistulotomy, fistula plug, fibrin glue, advancement flap (AF), ligation of inter-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, martius procedure, 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.
2. 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 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 Ulcerative Colitis, and Crohn's Disease (CD).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04940611
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohns Disease, Fistula, Rectovaginal Fistula, Complex Perianal Fistula, Complex Cryptoglandular Fistula
Additional Details

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.

Arms & Interventions

Arms

: Participants With CPF-CD

Participants diagnosed with CPF-CD will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.

: Participants With CD-RVF

Participants diagnosed with CD-RVF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.

: Participants With CCF

Participants diagnosed with CCF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center,, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center,

Los Angeles, California, 90048

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