Clinical trial · Interventional
Case Series With Saneso 3600 Colonoscope
NCT05505370CI-TRIAL-00060376completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Saneso colonoscope is a novel FDA cleared colonoscope that provides a 360 degree integrated view of the colon. Saneso colonoscope has five cameras and multiple LED lights at the distal head. The objective of the present study is to evaluate clinical success of the Saneso colonoscope in intubation of the terminal ileum and to obtain user feedback with regards to usability characteristics compared to predicate devices.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Arm Study device
- description
- Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist.
- interventionNames
- Device: Colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Study Arm - Predicate Device
- description
- Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist.
- interventionNames
- Device: Colonoscopy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * 45 -74 years of age Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Scheduled for a clinically indicated routine colonoscopy procedure ASA class 1-3. Exclusion Criteria: * Altered colon anatomy Pregnant women, children under 18 years of age and adults over 75 years of age. Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor ASA class 4-5.
References
Publications (0)
Data not yet available
No reference posted for this study.