Clinical Utility Evidence for TissueCypher®

Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for TissueCypher®: A CPV® Randomized Controlled Trial

Cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be provided to all participating physicians and submitted to a national journal for publication. The study plans to enroll up to 249 physicians.

Inclusion Criteria:

• Board-certified gastroenterologist or GI surgeon for at least two years
• Averages at least 20 hours per week of clinical and patient care duties over the last six months
• performs either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
• practicing in the US
• english speaking
• access to the internet
• informed and voluntarily consented to be in the study

Exclusion Criteria:

• non-English speaking
• unable to access the internet
• not practicing in the US
• not averaging at least 20 hours per week of clinical or patient care duties over the last six months
• does not perform either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
• does not voluntarily consent to be in the study