Gentle Colonoscopy Clinical Trial
Official title:
Open Label, Multi-center, Single Arm Post-marketing Study of SC20 Colonoscope and Colonoscopy System for Colonoscopy in Male and Female Patients >18 Years Old
The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population.
The objective of the study is to expand data collection and product exposure in a controlled
clinical setting and gather data regarding the performance of the Invendo SC20 colonoscope
in a real-world US population. The objective of the study is to specifically monitor three
points:
1. The diagnostic performance of the device including polyp and adenoma detection rates;
2. The therapeutic performance of the device (the ability of the physician to
remove/biopsy identified lesions);
3. Performance of the device in a typical colonoscopy population, including patients with
underlying inflammatory bowel disease (IBD), previous pelvic surgery or irradiation,
obesity, diverticular disease, and previous colorectal surgery, as they present in the
study population (see below C.).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening