Adults 45 to 75, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adenoma Miss RatesPrimary· Through study completion, an average of one year
Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology.
Three (3) lesions were missed by the Aer-OScope and detected with the subsequent conventional colonoscopy. Two (2) polyps were not removed and an additional one (1) was not retrieved.
Data was missing for two (2) lesions by the Conventional Colonoscopy (CC)
Group
Value
95% CI
Aer-O-Scope First
3
Conventional Colonoscope First
2
Polyp Miss Rates (PMR) for Each Study ArmSecondary· Through study completion, an average of one year
Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass
Group
Value
95% CI
Aer-O-Scope First
4
Conventional Colonoscope First
2
Advanced Adenoma Miss Rates (AAMR) for Each Study ArmSecondary· Through study completion, an average of one year
Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology.
Group
Value
95% CI
Aer-O-Scope First
0
Conventional Colonoscope First
0
Sponsor's own description
This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GI View Ltd.
Last refreshed: 16 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02926209.