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Completed

NCT Number: NCT01955122

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elisha Medical Center, Haifa, Please Select, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tandem Colonoscopy

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. Sedation

    Time frame: During the procedure

    Sedation dosage

  4. Scope Centering Ability

    Time frame: During the procedure

    Ability to center the scope inside the gastrointestinal tract.

  5. Colon Area Screened

    Time frame: During the procedure

    Subjective evaluation of the additional area screened by the physician.

  6. 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

Sponsors and collaborators

Lead sponsor

EndoAid

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2013
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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