Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study

EndoAid

Status: Completed

Conditions: Colon Cancer

Treatments: Device: Tandem Colonoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01955122

TSDPR100

Details and patient eligibility

About

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.

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 EndoRings™ colonoscopy. Subjects in Group B (control group) will undergo an EndoRings™ 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.

Enrollment: 126 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Group A

Other group

Description:

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.

Treatment:

Device: Tandem Colonoscopy

Group B

Other group

Description:

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.

Treatment:

Device: Tandem Colonoscopy