Status:
COMPLETED
Clinical Study to Establish the Feasibility and Usability of the EndoRings™
Lead Sponsor:
EndoAid
Conditions:
Colon Cancer
Bowel Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.
Detailed Description
The EndoAid Ltd. EndoRings is used during endoscopy procedures. The EndoRings is a short silicon rubber tube with flexible circular wings that attaches to the distal end of the endoscope to facilitate...
Eligibility Criteria
Inclusion
- Any subject who meets all of the following criteria may be included in this study:
- Subject between the ages of 18 and 70
- The patient is undergoing colonoscopy for screening, or 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
- Any subject who meets any of the following criteria will not be included in this study:
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01868971
Start Date
April 1 2013
End Date
October 1 2013
Last Update
July 28 2017
Active Locations (1)
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1
Elisha Medical Center
Haifa, Please Select, Israel, 34601