NCT06935734

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

Colonoscopy With a Robotic Endoscope, The CARE I Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Neptune Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colonoscopy
• Colorectal Cancer Screening
• Colorectal Neoplasms
• Gastrointestinal Endoscopy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic Colonoscopy	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.

Timeline

• Start date: 2025-04-14
• Primary completion: 2025-06-06
• Completion: 2025-07-31
• First posted: 2025-04-20
• Last updated: 2025-04-20