NCT02279836

Single Arm Post-marketing Study of SC20 Colonoscope

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Invendo Medical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.).

Conditions

• Gentle Colonoscopy

Interventions

Type	Name	Description
DEVICE	SC20 Colonoscope	Single Arm Post-Marketing Study of SC20 Colonoscope

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-10-01
• Completion: 2016-01-01
• First posted: 2014-10-31
• Last updated: 2015-02-04

Locations

3 sites across 1 country: United States