Trials / Completed
CompletedNCT03949777
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- GI View Ltd. · Industry
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
Detailed description
This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures. Up to the first ten (10) cases for each physician will be system operation training cases. The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.
Conditions
- Colonic Polyp
- Colonic Neoplasms
- Colonic Diseases
- Colon Adenoma
- Colon Disease
- Colon Adenocarcinoma
- Colon Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aer-O-Scope Colonoscopy | resection or biopsy of colonic abnormalities for histopathalogical evaluation |
Timeline
- Start date
- 2020-01-06
- Primary completion
- 2021-08-10
- Completion
- 2021-11-14
- First posted
- 2019-05-14
- Last updated
- 2021-11-18
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT03949777. Inclusion in this directory is not an endorsement.