Triton 1.5 Robotic System for Diagnostic Colonoscopy

NCT07606963 | Not Yet Recruiting

• 1 other identifier: CP-000005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, non-randomized, single-site study, focused on evaluating the safety and efficacy of the Triton 1.5 System in diagnostic and basic therapeutic colonoscopy.

Conditions

Colonoscopy; Colorectal Cancer Screening; Colorectal Neoplasms; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours

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

  48 Hours

• Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure

  Completion of colonoscopy defined by both: (a) Successful cecal intubation with visualization of the appendiceal orifice, (b) Successful withdrawal with clinically acceptable diagnostic inspection and therapeutic access.

  During Procedure

Secondary Outcomes (8)

• Secondary Safety Endpoint - Mucosal Injury Score During Procedure

  During Procedure

• Secondary Safety Endpoint - Delayed Bleeding Within 14 Days

  14 days post-procedure

• Secondary Safety Endpoint - Delayed Perforations Within 14 Days

  14 days post-procedure

• Secondary Efficacy Endpoint - Time to Cecum During Procedure

  During Procedure

• Secondary Efficacy Endpoint - Need for Repositioning During Procedure

  During Procedure

Study Arms (1)

Single Arm

OTHER

This study is a prospective, single-arm, non-randomized, single-site study, which is deigned to evaluate the safety and efficacy of the Triton 1.5 System for performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm) during endoscopic procedures.

Device: Diagnostic Test: Diagnostic Colonoscopy

Interventions

Diagnostic Test: Diagnostic Colonoscopy DEVICE

This study will serve to evaluate the safety and efficacy of the Triton 1.5 System for performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm).

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 protocol specific procedures
• Subject is willing and able to comply with all protocol required preparation and follow- up visits

You may not qualify if:

• Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
• Any active or magnetic 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
• Subject 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
• History of mesenteric ischemia

Sponsors & Collaborators

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

Study Sites (1)

HT Centrum Medyczne

Tychy, Silesian Voivodeship, 43-100, Poland

Location

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, MD

  H-T Centrum Medyczne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayley Holm

CONTACT

(650) 922-5512; hayley.holm@neptunemedical.com

Min-Sun Son

CONTACT

(650) 714-1803; minsun@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: May 11, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)