A Study of Surgical Interventions in Fistulizing Conditions

ClinicalTrials.gov ID: NCT04940611

Public ClinicalTrials.gov record NCT04940611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04940611
Recruitment status: Completed
Study type: Observational
Phase: Not listed
Lead sponsor: Takeda; Industry
Enrollment: 646 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 5, 2021 (Actual)
Primary completion: Apr 30, 2025 (Actual)
Completion: Apr 30, 2025 (Actual)
Last update posted: May 1, 2026

2021 – 2025

United States locations

U.S. sites: 13
U.S. states: 10
U.S. cities: 12

Facility	City	State	ZIP	Site status
Cedars-Sinai Medical Center	Los Angeles	California	90048	—
Baptist MD Anderson Cancer Center	Jacksonville	Florida	32207	—
University of South Florida - PARENT	Tampa	Florida	33612	—
University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas	66160	—
GI Alliance - Baton Rouge	Baton Rouge	Louisiana	70809	—
Lenox Hill Hospital PRIME	New York	New York	10075	—
UNC Hospitals	Chapel Hill	North Carolina	27599	—
Premier Health	Dayton	Ohio	45409	—
Penn Medicine PA	Philadelphia	Pennsylvania	19104	—
Temple University Hospital	Philadelphia	Pennsylvania	19140	—
Vanderbilt University Medical Center- GI Endoscopy Lab	Nashville	Tennessee	37212	—
Baylor Research Institute	Dallas	Texas	75204	—
Colon & Rectal Clinic	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04940611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 1, 2026 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04940611 live on ClinicalTrials.gov.

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