An interventional study of Diagnostic Test: Diagnostic Colonoscopy in Colonoscopy and Colorectal Cancer Screening, sponsored by Neptune Medical. Not yet recruiting at 1 site in United Arab Emirates. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Neptune Medical · Not applicable, Interventional, and Diagnostic
The purpose of this study is to gain early experience in the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2 cm). This study will be the first clinical experience with Triton 1.5 in the Middle East, conducted at Cleveland Clinic Abu Dhabi.
The study will include up to 10 patients for operator training and familiarization with the Triton 1.5 System. Data from the training phase will be collected for operational and safety review but will not contribute to the primary or secondary endpoint analyses. Up to 20 subjects will undergo robotic colonoscopy to evaluate the performance of Triton 1.5 System in diagnostic, screening, surveillance colonoscopies, which are inclusive of basic therapeutic tasks, such as polypectomy for lesions ≤ 2 cm.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 30 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Neptune Medical is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intra-Operative Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This study will serve to gain early experience in the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm).
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
Time frame: 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.
Time frame: During Procedure
Secondary Safety Endpoint - Mucosal Injury Score During Procedure
Mucosal Injury graded using a visual assessment of the colonic wall during withdrawal of the procedure using the following scale: (1) Erythema / Bruising, (2) Mucosal break \< 5 mm, (3) Mucosal break \> 5 mm, (4) Muscle injury (non-full thickness), (5) Full-thickness injury. Unit of Measure: Score (1-5), higher scores indicate more severe injury
Time frame: During Procedure
Secondary Safety Endpoint - Delayed Bleeding Within 14 Days
Delayed bleeding within 14 days, defined as: bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop \> 2 g, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia).
Time frame: 14 days Post-Procedure
Secondary Safety Endpoint - Delayed Perforations Within 14 Days
Delayed perforations within 14 days, defined as: perforations occurring within 14 days post-procedure.
Time frame: 14 days Post-Procedure
Secondary Efficacy Endpoint - Time to Cecum During Procedure
Interval from nested-system insertion at the anal verge to first visualization of the appendiceal orifice. Pauses for ancillary or therapeutic tasks (e.g., biopsy, polypectomy ≤ 2 cm, repositioning, prolonged washing) are recorded and subtracted to isolate insertion performance. For polypectomy pauses, time is measured from first polyp visualization to confirmation of retrieval in the specimen trap. Unit of Measure: Minutes or seconds
Time frame: During Procedure
Secondary Efficacy Endpoint - Need for Repositioning During Procedure
Number of times a participant was repositioned during the procedure. Unit of Measure: Number of repositioning events
Time frame: During Procedure
Secondary Efficacy Endpoint - Polypectomy Success During Procedure
Clinically acceptable polypectomy performed with cold forceps, cold snare, or hot snare leaving no visible residual polyp. Polyps \> 2 cm or lesions too complex for diagnostic colonoscopy are excluded and deferred for later advanced therapy.
Time frame: During Procedure
Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure
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 (0-600)
Time frame: Immediately after Procedure
Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure
Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma. Unit of Measure: Percentage of participants
Time frame: Within 30 days Post-Procedure
Secondary Efficacy Endpoint - Patient-Reported Discomfort
Patient experience during colonoscopy, evaluated by asking the patient the following questions during recovery after the procedure on the same day. Patients are asked two questions: 1. How much of the procedure do you remember or were aware of? (0 = nothing at all, 10 = everything), and 2. During the procedure, how much discomfort or pain did you experience? (0 = none, 10 = worst imaginable)?
Time frame: Up to 24 Hours Post-Procedure
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.
Of 57 industry-sponsored interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 1 month is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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