Single Arm Post-marketing Study of SC20 Colonoscope

Study Overview
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Brief Summary
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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
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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: The diagnostic performance of the device including polyp and adenoma detection rates; The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions); 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.).

Official Title
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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

Conditions
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Gentle Colonoscopy

Intervention / Treatment
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* Device: SC20 Colonoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any indication for colonoscopy Willing to give informed consent Willing to consume 2-4 liters of bowel prep Exclusion Criteria: An age younger than 18 years Congestive heart failure Renal insufficiency Intestinal obstruction Any acute life-threatening condition (in the opinion of the investigator) Current pregnancy Abdominal surgery in the past 6 months Bleeding disorders Inability to provide informed consent Any other contraindication to colonoscopy (e.g. fulminant colitis or acute diverticulitis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm post-marketing Study<br>SC20 Colonoscope and Colonoscopy System For Colonoscopy | Device: SC20 Colonoscope<br>* Single Arm Post-Marketing Study of SC20 Colonoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure) |  | average 6 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Detection of polyps, adenomas and other lesions in all individuals |  | average 6 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with any indication for colonoscopy in the U.S.A.