Colon Cancer Clinical Trial
Polyp Detection With the EndoRingsâ„¢: A Randomized Tandem Colonoscopy Study
Summary
To compare the adenoma miss rate with the EndoRingsâ„¢ vs. the adenoma miss rate with Standard view colonoscopy.
To compare the polyp miss rate with the EndoRingsâ„¢ 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.
Full Description
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.
Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by an EndoRingsâ„¢ colonoscopy. Subjects in Group B (control group) will undergo an EndoRingsâ„¢ colonoscopy followed immediately by a Standard view colonoscopy.
Results from the two groups will be analyzed and compared, with primary outcome measures being adenoma miss rate and polyp miss rate. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.
Subjects will be followed through a 24 hour and a 7-days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
Multi-center study with up to 126 patients. Up to 126 treated patients (2 groups of 57 patients +6 drop-out patients) will be enrolled into the study.
Eligibility Criteria
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.
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There are 2 Locations for this study
Indianapolis Indiana, 46202, United States
Haifa Please Select, 34601, Israel
Utrecht , , Netherlands
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