ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
Phase 1
- Conditions
- Colon Cancer
- 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.
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
- 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