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

Colonoscopy With a Robotic Endoscope, The CARE I Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Colonoscopy; Gastrointestinal Endoscopy; Colorectal Cancer Screening
• Intervention / Treatment: Diagnostic test: Diagnostic Colonoscopy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aishwarya Gosai; Phone Number: (949) 394 8073; Email: aishwarya@neptunemedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

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

Exclusion Criteria:

Initial Screening / Pre-Operative:

1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
2. Any active implantable medical devices (e.g., pacemakers, defibrillators)
3. Previous failed colonoscopy (except for inadequate bowel preparation)
4. BMI > 45 kg/m2
5. Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
6. Surgically altered colonic anatomy
7. 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
8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies
10. Patient receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
11. Known colonic stricture
12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
13. Known abdominal wall hernias
14. History of radiotherapy to the abdomen or pelvis
15. History of mesenteric ischemia
16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
17. Contraindication to the proposed sedation / anesthesia
18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure

20. Participation in any concurrent clinical trial that may impact the results of this study

    Intra-Operative Exclusion Criteria:

21. Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) < 2 in any section
22. Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A
23. Any presenting condition discovered intraoperatively that in the opinion of the investigator would make participating in this study not in the participant's/patient's best interest. For example, presence of a stricture or tight sigmoid that would make passing an overtube risky for the patient
24. Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Device-related death within 48 hours; Perforation within 48 hours; Intraprocedural bleeding preventing completion of the procedure; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Cecum	Time from scope insertion to successful cecal intubation. Unit of Measure: Minutes	During procedure
Need for Repositioning	Number of times a participant was repositioned to facilitate scope advancement. Unit of Measure: Number of repositioning events	During procedure
Polypectomy Success	If applicable, indicates whether at least one polyp was successfully removed using standard polypectomy tools during the procedure. This outcome is evaluated per participant and applies only to Phase B (robotic procedures). Unit of Measure: Categorical - Yes / No / Partial (i.e., at least one polyp removed, but not all targeted polyps).	During procedure
NASA Task Load Index (NASA-TLX)	Physician's subjective workload assessment using the NASA Task Load Index (NASA-TLX), a validated tool consisting of six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored from 0 to 100 in increments of 5. Higher scores indicate greater perceived workload. Unit of Measure: Composite score (0-100)	Post-procedure
Mucosal Injury Score	Mucosal injury graded using a 5-point ordinal scale based on injury severity: 1 = Erythema/ Bruising, 2 = Mucosal break <5mm in length, 3 = Mucosal break >5mm in length, 4 = Mucosal Injury (non-full thickness), 5 = Full thickness injury. Outcome is reported per subject. Only applicable to Phase B (robotic procedures). Unit of Measure: Score (1-5); higher scores indicate more severe injury	During procedure
Delayed Bleeding (14 Days)	Number of participants with delayed bleeding within 14 days confirmed by pre-determined symptoms and hemoglobin drop of >2 g/dL. Unit of Measure: Number of participants	14 days
Delayed Perforation (14 Days)	Number of participants with delayed perforation identified within 14 days post-procedure. Unit of Measure: Number of participants	14 days
Adenoma Detection Rate (ADR)	Proportion of participants in whom at least one adenomatous polyp is detected during the robotic colonoscopy procedure. Applicable to Phase B (robotic procedures) only. Unit of Measure: Percentage of participants with ≥1 adenoma detected	During procedure

Collaborators and Investigators

• Sponsor: Neptune Medical
• Collaborators: H-T. Centrum Medyczne Sp. z o.o. sp. k; KCRI
• Investigators: Principal Investigator: Marcin Romanczyk, H-T Centrum Medyczne; Principal Investigator: Jason Samarasena, MD, University of California, Irvine; Principal Investigator: Tomasz Romanczyk, H-T Centrum Medyczne

Study record dates

Study Major Dates

• Study Start (Estimated): April 14, 2025
• Primary Completion (Estimated): June 6, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CP-000001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No