ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the ProtectiScope CS is capable to perform diagnostic and therapeutic colonoscopy.

Detailed Description
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The ProtectiScope CS is a disposable-based colonoscope incorporating a miniature video camera,integral light source along with single-use sleeves and application Channels. The ProtectiScope CS is intended to provide visualization and therapeutic access to the Lower Gastrointestinal Tract, in adult patient populations.

Official Title
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Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases

Conditions
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Colon Cancer

Intervention / Treatment
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* Device: Protectiscop CS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject between the ages of 18 and 80 Subject is indicated for screening colonoscopy Subject is willing to sign informed consent form Exclusion Criteria: Subject is suspected, based on radiographic or other clinical grounds, of suffering from one or more of the following: full or partial colonic obstruction; acute abdomen; gross hematochezia; severely ulcerated colon; diverticulitis; severe diverticulosis; toxic megacolon. Subject has active cardiac problems and history of heart failure, severe pulmonary diseases renal failure (creatinine >2) uncontrolled diabetes and any other illness judged by investigator to substantiate exclusion. Subject has a history of significant other diseases. Subject has a history of psychiatric disorders which would prevent compliance with study instructions For female subjects, suspicion of pregnancy Subject has received treatment with another investigational drug or device within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Protectiscop CS<br>* Patients who are indicated for screening colonoscopy will be recruited into the trial. The ProtectiScope CS sleeve is assembled on the colonoscope.standard colonoscopy is performed. Subjects will be followed for 1-month post procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the success rate in reaching within working distance of the Cecum with no complications. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability to perform routine therapeutic interventions such as biopsies, polypectomies, APC etc. as compared to therapeutic interventions with standard colonoscopes found in the literature. |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, disposable, single use