Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-29 @ 3:35 AM
Study NCT ID:
NCT06935734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions
Sponsor:
Neptune Medical
Organization:
Study Overview
Official Title:
Colonoscopy With a Robotic Endoscope, The CARE I Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE I
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: