Clinical trial · Interventional
Feasibility Study of a Novel Single Use Robotic Colonoscopy System
A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Feasibility of Novel Single Use Robotic Colonoscopy System ("NISInspire-C System") in Human Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single centre, non-randomized, tandem colonoscopy trial of the NISInspire-C System, followed immediately by a conventional colonoscope (CC). Each trial subject will undergo colonoscopy using the NISInspire-C system, followed immediately by CC. The purpose of this study is to obtain observational data on the safety profile, feasibility and usability of the NISInspire-C System in performing diagnostic colonoscopy in human subjects. The level of procedural pain experienced by subjects will also be explored.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenoma | Colon Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colonic Polyp | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NISInspire-C System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subjects Receiving Colonoscopy
- description
- Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy
- interventionNames
- Device: NISInspire-C System
Primary outcomes (4)
- measure
- Safety: Incidence of Intra-Operative and Post-Operative Adverse Events
- timeFrame
- 10 Days
- description
- Number of Adverse Events
- measure
- Feasibility: Caecal Intubation Rate (CIR)
- timeFrame
- 1 Hour
- description
- CIR: Number of Times Caecum is Reached
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Males aged between 40 and 70 years, inclusive, at the time of informed consent * Females aged between 55 and 70 years, inclusive, at the time of informed consent (Rationale: to include only women with non-childbearing potential to avoid completely pregnant trial subjects) * Symptomatic adults indicated for elective colonoscopy, or asymptomatic adults willing to undergo a colonoscopic screening for polyps or colorectal cancer * Adults without prior colonoscopy * Able to provide a written informed consent form approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study-specific procedures * Willing and able to comply with the study procedures Exclusion Criteria: * History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, familial polyposis coli, hereditary nonpolyposis colorectal cancer syndrome, active diverticulitis or toxic megacolon * Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day * Known bleeding tendency * Received antiplatelet or anticoagulation therapy within 3 days prior to the colonoscopy day * Known colonic stricture * Known multiple sigmoid colon diverticula * History of any abdominal or pelvis surgical procedures including colonic and rectal surgical resection * Known abdominal wall hernias * History of radiotherapy to the abdomen or pelvis * Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy day * Contraindication to the proposed anaesthesia * Received any investigational medicine or treatment within 28 days prior to Screening * 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
References
Publications (0)
Data not yet available