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NCT04940611 · ClinicalTrials.gov registry record
A Study of Surgical Interventions in Fistulizing Conditions
A clinical trial of Crohn's Disease and Fistula, sponsored by Takeda.
- Active
- Registry status
- 750
- Enrollment target
- 20
- Study locations
NCT04940611: Active study of Crohn's Disease and Fistula, sponsored by Takeda.
NCT04940611 is a study of Crohn's Disease and Fistula that is active but no longer recruiting, run by Takeda. The registered enrollment target is 750 participants, below the 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04940611, a study of Crohn's Disease and Fistula, is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- 750 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Clinical remission for Complex perianal fistula in Crohn's Disease (CPF-CD) and Complex Cryptoglandular Fistula (CCF) is defined as closure of all index treated external fistula openings that were draining at baseline as assessed clinically despite gentle finger compression. Clinical remission for Rectovaginal fistula with Crohn's Disease (CD-RVF) is defined as epithelization of the index external fistula opening (vaginal opening) compared to baseline.
Conditions Studied
Study Locations (20)
Other
- AKH - Medizinische Universitat Wien - Vienna
- UZ Antwerpen - Antwerp
- Cliniques Universitaires Saint-Luc - Brussels
- Jessa Ziekenhuis Hospital - Hasselt
- Clinique CHC MontLegia - Liège
- AZ Delta - Roeselare
Florida
- Baptist MD Anderson Cancer Center - Jacksonville
- University of South Florida - PARENT - Tampa
Pennsylvania
- Penn Medicine PA - Philadelphia
- Temple University Hospital - Philadelphia
Texas
- Baylor Research Institute - Dallas
- Colon & Rectal Clinic - Houston
California
- Cedars-Sinai Medical Center - Los Angeles
Kansas
- University of Kansas Medical Center Research Institute, Inc. - Kansas City
Louisiana
- GI Alliance - Baton Rouge - Baton Rouge
New York
- Lenox Hill Hospital PRIME - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2021-08-05 |
| Est. Completion | 2026-05-02 |
What the registry record for NCT04940611 still lists
NCT04940611 is an observational study that tracks outcomes without assigning an intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, below the 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (69% lower).
The record links to 5 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 0 interventions.
NCT04940611 names 20 study sites across 12 states, led by Other, Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04940611 about?
NCT04940611 is a clinical study titled "A Study of Surgical Interventions in Fistulizing Conditions". 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 comple...
What is the current status of trial NCT04940611?
This trial is currently active not recruiting. The enrollment target is 750 participants. The study started on 2021-08-05. Estimated completion is 2026-05-02.
What conditions does trial NCT04940611 study?
This clinical trial studies the following conditions: Crohn's Disease, Fistula, Complex Perianal Fistula, Rectovaginal Fistula, Complex Cryptoglandular Fistula.
Who is sponsoring clinical trial NCT04940611?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04940611 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04940611's enrollment target sits among peer trials
750 16th of 105 higher than 90 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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