An interventional study of Diagnostic Colonoscopy in Colonoscopy, Colorectal Cancer Screening and Colorectal Neoplasms, sponsored by Neptune Medical. Not yet recruiting. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Neptune Medical · Not applicable, Interventional, and Diagnostic
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 50 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.
Counted across the registry records on this site, refreshed daily.
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:
Initial Screening / Pre-Operative:
Participation in any concurrent clinical trial that may impact the results of this study
Intra-Operative Exclusion 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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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 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.
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
Time frame: 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).
Time frame: During procedure
Time to Cecum
Time from scope insertion to successful cecal intubation. Unit of Measure: Minutes
Time frame: During procedure
Need for Repositioning
Number of times a participant was repositioned to facilitate scope advancement. Unit of Measure: Number of repositioning events
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 14 days
Delayed Perforation (14 Days)
Number of participants with delayed perforation identified within 14 days post-procedure. Unit of Measure: Number of participants
Time frame: 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
Time frame: During procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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