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

NCT06935734 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • H-T. Centrum Medyczne Sp. z o.o. sp. k

    collaborator OTHER

  • Neptune Medical

    lead INDUSTRY

Principal Investigators

  • Marcin Romanczyk · H-T Centrum Medyczne

  • Jason Samarasena, MD · University of California, Irvine

  • Tomasz Romanczyk · H-T Centrum Medyczne

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-14
Primary Completion
2025-06-06
Completion
2025-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935734 on ClinicalTrials.gov