Colorectal Cancer Clinical Trial
Official title:
EndoRings™ - Clinical Protocol
The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.
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 endoscopic therapy.
The EndoRings is designed to fit specific endoscopes (as designated on the packaging), and is
supplied sterile following ETO sterilization and is single use only.
Indications for Use:
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be
used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
Patient Population: The study population is comprised of patients indicated for colonoscopy.
Study Design: Single-center study. A single treatment group of 60 patients. No. of Patients:
Up to sixty (60) treated patients will be enrolled in the study.
Primary Endpoints:The primary endpoint is reaching the cecum of the colon with the
ENDORINGS™.
Secondary Endpoints / Other Outcomes:
1. Incidence of complications (number of complications)
2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.
3. Procedure time.
4. Ease of scope insertion, advancement and withdrawal.
5. Ability to center the scope inside the gastrointestinal tract.
6. Subjective evaluation of the additional area screened by the physician (recorded in the
source documents by a questionnaire).
7. Patient satisfactory (by a follow up phone-call in which questionnaire with VAS scale
will be filled out).
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