Clinical Utility Evidence for TissueCypher®

Qure Healthcare

Status: Completed

Conditions: Barrett Esophagus; Gastro-Intestinal Disorder

Treatments: Other: Educational materials for TissueCypher

Study type: Interventional

Funder types: Industry

Identifiers

NCT05200325

Pro00056136

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 3 patient groups

Control Group

No Intervention group

Description:

The control group does not receive educational materials about the TissueCypher diagnostic test and will treat their simulated patients with the current standard of care tools.

Intervention Group 1

Experimental group

Description:

Intervention group 1 receives educational materials about the TissueCypher diagnostic test. These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. This intervention group is then forced to use the test results in treating their simulated patients.

Treatment:

Other: Educational materials for TissueCypher

Intervention Group 2

Experimental group

Description:

Intervention group 2 receives educational materials about the TissueCypher diagnostic test. These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. This intervention group then gets to decide whether or not they want to use the TissueCypher test results for their simulated patients.

Treatment:

Other: Educational materials for TissueCypher