Colon Cancer Clinical Trial
Official title:
Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard
view colonoscopy.
To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard
view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal
and overall procedure time will be analyzed and reported for each group.
Status | Completed |
Enrollment | 126 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Subject between the ages of 40 and 75 - 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 Exclusion Criteria: - Patients with a history of colonic resection; - Patients with known (or newly diagnosed) 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 with a hemorrhagic diathesis - Patients with acute lower GI bleeding - Pregnant women and women with childbearing potential without adequate contraception - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | Elisha Medical Center | Haifa | Please Select |
Netherlands | University Medical Center Utrecht | Utrecht | |
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
EndoAid |
United States, Israel, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma and polyp miss rate | Standard colonoscopy adenoma miss rate compared to the adenoma miss rate using the EndoRings™. Standard colonoscopy polyp miss rate compared to the polyp miss rate using the EndoRings™ | 24 hours post procedure | No |
Secondary | Theraputic interventions | Performance of therapeutic interventions, such as biopsies, polypectomies, APC etc. | 24 hours post procedure | No |
Secondary | Procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured | The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured | During the procedure | No |
Secondary | Sedation | Sedation dosage will be recorded | During the procedure | No |
Secondary | Scope centering ability | Ability to center the scope inside the gastrointestinal tract. | During the procedure | No |
Secondary | Colon area screened | Subjective evaluation of the additional area screened by the physician. | During the procedure | No |
Secondary | Patient satisfaction | Patient's pain at the end of the procedure will be recorded using VAS scale. Results of 24 hour telephone follow-up to assess for post-procedural patient satisfactory will be recorded on the CRF. | 24 hours post procedure | No |
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