Effectiveness and safety study of Cosmo CB-17-08 medical device

• Research type

  Research Study

• Full title

  Prospective, randomized, multicenter, tandem study evaluating the safety and effectiveness of the CB-17-08 Augmented Endoscopy System for the detection of mucosal colorectal polyps in adult patients undergoing screening or surveillance colonoscopy for CRC.

• IRAS ID

  276609

• Contact name

  James East

• Contact email

  james.east@ouh.nhs.uk

• Sponsor organisation

  Cosmo AI Ltd.

• Clinicaltrials.gov Identifier

  NCT03954548

• Duration of Study in the UK

  0 years, 4 months, 24 days

• Research summary

  The study will investigate the safety and effectiveness of a medical device called CB-17-08, a Computer Aided Detection software (CADe) trained to detect potential colorectal polyps, as adjunct to standard colonoscopy.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  20/SC/0015

• Date of REC Opinion

  13 Feb 2020

• REC opinion

  Further Information Favourable Opinion