ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-01-31

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.

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Protectiscop CS

Intervention Type DEVICE

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.

Interventions

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Protectiscop CS

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes