Health TrialsbyHealthPanel

Triton 1.5 Robotic System for Diagnostic Colonoscopy in the Middle East

ConditionsColonoscopyColorectal Cancer Screening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorNeptune Medical

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Diagnostic Test: Diagnostic Colonoscopy

    Device

    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).

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neptune Medical

Lead sponsor

KCRI

Collaborator

Cleveland Clinic Abu Dhabi

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: