ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

Phase 1

• Conditions: Colon Cancer
• Interventions: Device: Protectiscop CS

• Registration Number: NCT00715325
• Lead Sponsor: Stryker GI Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-07-13
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-17
• Last Update Posted: 2008-09-18
• Study Start: 2008-10
• Primary Completion: 2008-12
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Protectiscop CS	-

Primary Outcome Measures

Name	Time	Method
To determine the success rate in reaching within working distance of the Cecum with no complications.	1 month

Secondary Outcome Measures

Name	Time	Method
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