Back to resultsProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Protectiscop CS
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer focused on measuring colonoscopy, disposable, single use
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
To determine the success rate in reaching within working distance of the Cecum with no complications.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00715325
Brief Title
ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
Official Title
Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Stryker GI Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colonoscopy, disposable, single use
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Protectiscop CS
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the success rate in reaching within working distance of the Cecum with no complications.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ori Segol, Dr.
Phone
+97248250359
Email
Ori_segol@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ori Segol, Dr.
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
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