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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955122
• Other study ID #: TSDPR100
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: July 16, 2014
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: EndoAid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthNetherlands: Medical Ethics Review Committee (METC)United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Device:
• Tandem Colonoscopy
Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device).

Locations

Country	Name	City	State
Israel	Elisha Medical Center	Haifa	Please Select
Netherlands	University Medical Center Utrecht	Utrecht
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
EndoAid

Countries where clinical trial is conducted

United States,  Israel,  Netherlands, 

Outcome

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