Clinical Trial

Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions

Study acronym: CARE I
Not Yet Recruiting
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Record status
This record was last updated April 20, 2025 (before its estimated June 6, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.
Trial Details
NCT Number NCT06935734
Lead Sponsor Neptune Medical
Collaborators: KCRI, H-T. Centrum Medyczne Sp. z o.o. sp. k
Conditions Colonoscopy, Colorectal Cancer Screening, Colorectal Neoplasms, Gastrointestinal Endoscopy
Enrollment 50 participants
Start Date 2025-04-14
Primary Completion 2025-06-06 (estimated)
Study Completion 2025-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-20