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ColonoscopyCARE INCT06935734

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

A study testing Diagnostic Colonoscopy in people with Colonoscopy and Colorectal Cancer Screening, run by Neptune Medical.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
What is being tested?
Diagnostic Colonoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
14 Apr 2025to 31 Jul 2025
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 Clinical Investigation Plan specific procedures
  • Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -

Who cannot join

  • Initial Screening / Pre-Operative:
  • Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
  • Any active 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).
Show all 26Show fewer
  • 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
  • Patient 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 Exclusion Criteria:
  • Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) < 2 in any section
  • Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A
  • 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
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Aishwarya Gosai contact

(949) 394 8073

aishwarya@neptunemedical.com

About this study

Official title: 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.

Being tested
Diagnostic Colonoscopy
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 ColonoscopyDiagnostic test

    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 groups in NCT06935734
Study groupRoleWhat they receive
Single ArmOtherThis 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.
Receives: Diagnostic Test: Diagnostic Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 48 hours

  2. 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).

    Measured: During procedure

Secondary outcomes (8)

  1. Time to Cecum

    Time from scope insertion to successful cecal intubation. Unit of Measure: Minutes

    Measured: During procedure

  2. Need for Repositioning

    Number of times a participant was repositioned to facilitate scope advancement. Unit of Measure: Number of repositioning events

    Measured: During procedure

  3. 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).

    Measured: During procedure

  4. 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)

    Measured: Post-procedure

  5. 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

    Measured: During procedure

  6. 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

    Measured: 14 days

  7. Delayed Perforation (14 Days)

    Number of participants with delayed perforation identified within 14 days post-procedure.

    Unit of Measure: Number of participants

    Measured: 14 days

  8. 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

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start14 Apr 2025 (estimated)
  3. Primary completion6 Jun 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935734
Sponsor's protocol ID
CP-000001
Acronym
CARE I
Status last verified
Apr 2025
First submitted
20 Mar 2025
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic Colonoscopy in people with Colonoscopy and Colorectal Cancer Screening, run by Neptune Medical.

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 26 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: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Aishwarya Gosai ((949) 394 8073, aishwarya@neptunemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Endpoint - Incidence 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?

On the ClinicalTrials.gov record for NCT06935734.

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 20 Apr 2025.

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