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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01955122
Recruitment Status : Completed
First Posted : October 7, 2013
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
EndoAid

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.


Condition or disease Intervention/treatment Phase
Colon Cancer Device: Tandem Colonoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
Study Start Date : July 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
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 Name: Colon screening

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 Name: Colon screening




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955122


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Israel
Elisha Medical Center
Haifa, Please Select, Israel, 34601
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
EndoAid
Investigators
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Study Director: Meytal Segev, DMD EndoAid Ltd.
Principal Investigator: Ian Gralnek, Prof. Rambam Health Care Campus
Principal Investigator: Ori Segol, Dr. Carmel Medical Center
Principal Investigator: Peter Siersema, Prof. UMC Utrecht
Principal Investigator: Douglas K. Rex, Dr. Indiana University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: EndoAid
ClinicalTrials.gov Identifier: NCT01955122    
Other Study ID Numbers: TSDPR100
First Posted: October 7, 2013    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by EndoAid:
polyp/adenoma miss rate
colonoscopy add-on device
enhanced screening
Additional relevant MeSH terms:
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Colonic Neoplasms
Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Pathological Conditions, Anatomical