ColonoscopyCARE IINCT07606963
Triton 1.5 Robotic System for Diagnostic Colonoscopy
A study testing Diagnostic Test: Diagnostic Colonoscopy in people with Colonoscopy and Colorectal Cancer Screening, run by Neptune Medical at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Colorectal Cancer Screening
- What is being tested?
- Diagnostic Test: Diagnostic Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 24 Aug 2026to 23 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
- Contraindication to the proposed sedation / anesthesia
- Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
- Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure
- Participation in any concurrent clinical trial that may impact the results of this study
- Intra-Operative Criteria:
- Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score < 2 in any segment.
- Any intraoperative finding or condition that, in the Investigator's judgment, would make study participation unsafe or not in the subject's best interest (e.g., significant stricture, tight sigmoid colon precluding safe overtube passage).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy
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.
Read the detailed description
This study is a prospective clinical investigation designed to evaluate the safety, and efficacy of the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2cm). Up to 40 subjects will undergo robotic colonoscopy using the Triton 1.5 System with three operating physicians.
- Conditions
- Colonoscopy, Colorectal Cancer Screening
- Being tested
- Diagnostic Test: Diagnostic Colonoscopy
- Keywords
- Colonoscopy, Colorectal Neoplasms, Gastrointestinal Endoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Diagnostic ColonoscopyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Diagnostic Test: Diagnostic Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: During Procedure
Secondary outcomes (8)
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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start24 Aug 2026
- Primary completion9 Sep 2026
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neptune Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI, H-T. Centrum Medyczne Sp. z o.o. sp. k
- Responsible party
- Sponsor
- Investigators
- Marcin Romanczyk, MD, Principal investigator, H-T Centrum Medyczne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606963
- Sponsor's protocol ID
- CP-000005
- Acronym
- CARE II
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy
- ClinicalTrials.gov ID
- NCT07606963
- Acronym / sponsor ID
- CARE II / CP-000005
- Conditions
- Colonoscopy, Colorectal Cancer Screening
- Keywords
- Colonoscopy, Colorectal Neoplasms, Gastrointestinal Endoscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Neptune MedicalIndustry (pharma, biotech, devices)
- Collaborators
- KCRI, H-T. Centrum Medyczne Sp. z o.o. sp. k
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective clinical investigation designed to evaluate the safety, and efficacy of the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2cm). Up to 40 subjects will undergo robotic colonoscopy using the Triton 1.5 System with three operating physicians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Diagnostic Test: Diagnostic ColonoscopyThis 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Diagnostic ColonoscopyThis 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). | Device | Single Arm |
Primary outcome
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
Time frame: 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
Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure
Time frame: 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.
8 secondary outcomes
Secondary Safety Endpoint - Mucosal Injury Score During Procedure
Time frame: During Procedure
Secondary Safety Endpoint - Delayed Bleeding Within 14 Days
Time frame: 14 days post-procedure
Secondary Safety Endpoint - Delayed Perforations Within 14 Days
Time frame: 14 days post-procedure
Secondary Efficacy Endpoint - Time to Cecum During Procedure
Time frame: During Procedure
Secondary Efficacy Endpoint - Need for Repositioning During Procedure
Time frame: During Procedure
Secondary Efficacy Endpoint - Polypectomy Success During Procedure
Time frame: During Procedure
Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure
Time frame: Immediately after Procedure
Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure
Time frame: During Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Romanczyk, MD principal investigator
H-T Centrum Medyczne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: Diagnostic Colonoscopy in people with Colonoscopy and Colorectal Cancer Screening, run by Neptune Medical at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours (time frame: 48 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.