NCT04940611

A Study of Surgical Interventions in Fistulizing Conditions

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Crohns Disease
• Fistula
• Rectovaginal Fistula
• Complex Perianal Fistula
• Complex Cryptoglandular Fistula

Timeline

• Start date: 2021-08-05
• Primary completion: 2026-05-02
• Completion: 2026-05-02
• First posted: 2021-06-25
• Last updated: 2026-02-18

Locations

41 sites across 10 countries: United States, Austria, Belgium, Canada, Czechia, France, Israel, Italy, Netherlands, United Kingdom