Clinical trial NCT01955122: Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
Official title: Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: polyp/adenoma miss rate
colonoscopy add-on device
enhanced screening
Lead sponsor: EndoAid
Sponsor class: INDUSTRY
First posted: 2013-10-07
Enrollment: 126
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Adenoma and Polyp Miss Rate
timeFrame: 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.
Secondary outcomes:
measure: Total Number of Therapeutic Interventions Performed
timeFrame: Interventions during procedure
measure: 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
timeFrame: During the procedure
measure: Sedation
timeFrame: During the procedure
measure: Scope Centering Ability
timeFrame: During the procedure
measure: Colon Area Screened
timeFrame: During the procedure
measure: Patient Satisfaction
timeFrame: 24 hours post procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Haifa
country: Israel
facility: Elisha Medical Center
state: Please Select
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: EndoAid Ltd.
name: Meytal Segev, DMD
role: STUDY_DIRECTOR
affiliation: Rambam Health Care Campus
name: Ian Gralnek, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carmel Medical Center
name: Ori Segol, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Peter Siersema, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Douglas K. Rex, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dik VK, Gralnek IM, Segol O, Suissa A, Belderbos TD, Moons LM, Segev M, Domanov S, Rex DK, Siersema PD. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy--results of the CLEVER study. Endoscopy. 2015 Dec;47(12):1151-8. doi: 10.1055/s-0034-1392421. Epub 2015 Jul 28.