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

NCT06935734 | Not Yet Recruiting DMC

• 1 other identifier: CP-000001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy; Colorectal Cancer Screening; Colorectal Neoplasms; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint - Incidence of Major Adverse Events Within 48 Hours

  Absence of Major Adverse Events (MAEs) within 48 hours of the procedure. MAEs are defined as any of the following: 1. Device-related death within 48 hours 2. Perforation within 48 hours 3. Intraprocedural bleeding preventing completion of the procedure 4. Delayed bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop of \>2 g, leading to admission to the hospital, prolongation of hospital stay, or another procedure requiring sedation/anesthesia. Unit of Measure: Number of participants with at least one Major Adverse Event

  48 hours

• Efficacy Endpoint - Successful Completion of Colonoscopy

  Completion of colonoscopy defined by both: (a) successful cecal intubation (clinically acceptable access and visualization of the cecum), and (b) successful withdrawal (clinically acceptable diagnostic and therapeutic access of the entire colon tract).

  During procedure

Secondary Outcomes (8)

• Time to Cecum

  During procedure

• Need for Repositioning

  During procedure

• Polypectomy Success

  During procedure

• NASA Task Load Index (NASA-TLX)

  Post-procedure

• Mucosal Injury Score

  During procedure

Study Arms (1)

Single Arm

OTHER

This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where the first phase (A) will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and the second phase (B) will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.

Diagnostic Test: Diagnostic Colonoscopy

Interventions

Diagnostic Colonoscopy DIAGNOSTIC_TEST

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.

Single Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 22 years
• Adults indicated for elective screening, surveillance or diagnostic colonoscopy
• Subject is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan specific procedures
• Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -

You may not qualify if:

• Initial Screening / Pre-Operative:
• Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
• Any active implantable medical devices (e.g., pacemakers, defibrillators)
• Previous failed colonoscopy (except for inadequate bowel preparation)
• BMI \> 45 kg/m2
• Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
• Surgically altered colonic anatomy
• History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon
• Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
• Known bleeding tendency such as hemophilia or coagulation factor deficiencies
• Patient receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
• Known colonic stricture
• Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
• Known abdominal wall hernias
• History of radiotherapy to the abdomen or pelvis

Sponsors & Collaborators

• Neptune Medical: lead
• KCRI: collaborator
• H-T. Centrum Medyczne Sp. z o.o. sp. k: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Marcin Romanczyk

  H-T Centrum Medyczne

  PRINCIPAL INVESTIGATOR

• Jason Samarasena, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Tomasz Romanczyk

  H-T Centrum Medyczne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aishwarya Gosai

CONTACT

(949) 394 8073; aishwarya@neptunemedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 20, 2025
• Study Start: April 14, 2025
• Primary Completion: June 6, 2025
• Study Completion: July 31, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04