Status:
UNKNOWN
ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
Lead Sponsor:
Stryker GI Ltd.
Conditions:
Colon Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 int...
Eligibility Criteria
Inclusion
- Subject between the ages of 18 and 80
- Subject is indicated for screening colonoscopy
- Subject is willing to sign informed consent form
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00715325
Start Date
October 1 2008
End Date
January 1 2009
Last Update
September 18 2008
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