PeerScope B System™ Clinical Protocol
Primary Purpose
Colon Cancer, Colon Diseases, Colon Polyps
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
colonoscopy system (PeerScope B System™)
Sponsored by
About this trial
This is an interventional screening trial for Colon Cancer focused on measuring wide angle view colonoscopy, PeerScope B System™
Eligibility Criteria
Inclusion Criteria:
- Subject between the ages of 18 and 70
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- Written informed consent must be available before enrollment in the trial
- For women with childbearing potential, adequate contraception
Exclusion Criteria:
- Patients with a history of colonic resection;
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
- Patients with a history of radiation therapy to abdomen or pelvis;
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Sites / Locations
- Elisha Medical Center
Outcomes
Primary Outcome Measures
The primary endpoint is reaching the cecum of the colon with PeerScope B S
a full colonoscopy procedure is characterized by reaching an anatomical mark (cecum)at the end of the insertion phase and then the physician start the withdrawal screening phase
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01483040
Brief Title
PeerScope B System™ Clinical Protocol
Official Title
a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PeerMedical Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population.
The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure.
The study population is comprised of patients indicated for colonoscopy.
The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints:
The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
The third secondary endpoint is the procedure time.
The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
The fifth secondary endpoint is patient satisfactory.
Detailed Description
Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of the button. The PeerScope B System™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal (GI) procedures with very limited learning curve and in service process. The current standard devices have viewing limitations. By adding this viewing functionality, PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colon Diseases, Colon Polyps, Colon Adenomas
Keywords
wide angle view colonoscopy, PeerScope B System™
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
colonoscopy system (PeerScope B System™)
Intervention Description
Cancer of the colon and rectum is second only to lung cancer as the leading cause of cancer-related deaths in the United States.Each year, about 1.23 million new cases of bowel cancer are diagnosed worldwide, 333,000 in Europe alone. Colorectal cancer almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible in a screening test known as colonoscopy. Recent research has shown that appropriate screening and treatment can alleviate much of the suffering associated with colorectal cancer and reduce the number of deaths caused by this malignancy
Primary Outcome Measure Information:
Title
The primary endpoint is reaching the cecum of the colon with PeerScope B S
Description
a full colonoscopy procedure is characterized by reaching an anatomical mark (cecum)at the end of the insertion phase and then the physician start the withdrawal screening phase
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject between the ages of 18 and 70
The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
Written informed consent must be available before enrollment in the trial
For women with childbearing potential, adequate contraception
Exclusion Criteria:
Patients with a history of colonic resection;
Patients with inflammatory bowel disease;
Patients with a personal history of polyposis syndrome;
Patients with suspected chronic stricture potentially precluding complete colonoscopy;
Patients with diverticulitis or toxic megacolon;
Patients with a history of radiation therapy to abdomen or pelvis;
Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Gralnek, Prof.
Organizational Affiliation
Ministry of Health, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elisha Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
PeerScope B System™ Clinical Protocol
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