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

January 15, 2017 updated by: EndoAid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Please Select
      • Haifa, Please Select, Israel, 34601
        • Elisha Medical Center
  • Netherlands
      • Utrecht, Netherlands
        • University Medical Center Utrecht
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Group A

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:

a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.
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) in a randomized order.
Other Names:
  • Colon screening
OTHER: Group B

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:

an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
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) in a randomized order.
Other Names:
  • Colon screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma and Polyp Miss Rate
Time Frame: 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.

Group A- we measured the Adenoma&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings).

Group B- we measured the Adenoma&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard).

Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group]*100
30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Therapeutic Interventions Performed
Time Frame: Interventions during procedure
Ability to perform therapeutic interventions, such as biopsies, polypectomies, APC etc. during the Standard Colonoscopy and during the EndoRings Colonoscopy. The number of interventions was not compared, this was just a safety outcome meant to prove there was no difficulty in performing interventions in both arms.
Interventions during procedure
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
Time Frame: During the procedure
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
Sedation
Time Frame: During the procedure
Sedation dosage
During the procedure
Scope Centering Ability
Time Frame: During the procedure
Ability to center the scope inside the gastrointestinal tract.
During the procedure
Colon Area Screened
Time Frame: During the procedure
Subjective evaluation of the additional area screened by the physician.
During the procedure
Patient Satisfaction
Time Frame: 24 hours post procedure
Follow up phone call was done 24 hours post procedure. Patients were asked the following : "On a 0 to 10 scale, with "0" being no pain and "10" being pain as bad as you can imagine, how would you describe your colonoscopy experience?" 0 1 2 3 4 5 6 7 8 9 10
24 hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoAid

Investigators

  • Study Director: Meytal Segev, DMD, EndoAid Ltd.
  • Principal Investigator: Ian Gralnek, Prof., Rambam Health Care Campus
  • Principal Investigator: Peter Siersema, Prof., UMC Utrecht
  • Principal Investigator: Douglas K. Rex, Dr., Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (ESTIMATE)

October 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSDPR100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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