ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether the ProtectiScope CS is capable to perform diagnostic and therapeutic colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2008
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedSeptember 18, 2008
September 1, 2008
2 months
July 13, 2008
September 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the success rate in reaching within working distance of the Cecum with no complications.
1 month
Secondary Outcomes (1)
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
Study Arms (1)
A
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Subject between the ages of 18 and 80
- Subject is indicated for screening colonoscopy
- Subject is willing to sign informed consent form
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stryker GI Ltd.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ori Segol, Dr.
Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2008
First Posted
July 15, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
September 18, 2008
Record last verified: 2008-09