NAVIGATE

• Research type

  Research Study

• Full title

  NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

• IRAS ID

  196286

• Contact name

  KELVIN LAU

• Contact email

  Kelvin.Lau@bartshealth.nhs.uk

• Sponsor organisation

  Medtronic

• Clinicaltrials.gov Identifier

  NCT02410837

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  The objective of this prospective, single-arm, multi-centre, post-market, observational study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system. The superDimension™ navigation system is an image-guided localization system used to
  navigate endoscopic tools to targets in the lungs, such as lymph nodes and solitary pulmonary nodules. The proposed post-market study will enrol up to 2,500 consecutive subjects at up to 75 sites worldwide, making it the largest prospective ENB™ clinical study to date. The 24-month follow-up of this study will also allow an assessment of the correlation between stage of diagnosis and long-term survival rates, in contrast to most prior ENB™ studies that evaluated only diagnostic yield and acute complication rates.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/0498

• Date of REC Opinion

  14 May 2016

• REC opinion

  Further Information Favourable Opinion