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

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Tandem Colonoscopy

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring polyp/adenoma miss rate, colonoscopy add-on device, enhanced screening

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Indiana University
Elisha Medical Center
University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Group A

Group B

Arm Description

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.

Outcomes

Primary Outcome Measures

Adenoma and Polyp Miss Rate

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

Total Number of Therapeutic Interventions Performed

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.

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

Sedation

Sedation dosage

Scope Centering Ability

Ability to center the scope inside the gastrointestinal tract.

Colon Area Screened

Subjective evaluation of the additional area screened by the physician.

Patient Satisfaction

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

Full Information

NCT ID

NCT01955122

First Posted

September 23, 2013

Last Updated

January 15, 2017

Sponsor

EndoAid

1. Study Identification

Unique Protocol Identification Number

NCT01955122

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EndoAid

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

polyp/adenoma miss rate, colonoscopy add-on device, enhanced screening

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Other

Arm Description

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.

Arm Title

Group B

Arm Type

Other

Arm Description

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.

Intervention Type

Device

Intervention Name(s)

Tandem Colonoscopy

Other Intervention Name(s)

Colon screening

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adenoma and Polyp Miss Rate

Description

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

Time Frame

30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.

Secondary Outcome Measure Information:

Title

Total Number of Therapeutic Interventions Performed

Description

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.

Time Frame

Interventions during procedure

Title

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

Description

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

Time Frame

During the procedure

Title

Sedation

Description

Sedation dosage

Time Frame

During the procedure

Title

Scope Centering Ability

Description

Ability to center the scope inside the gastrointestinal tract.

Time Frame

During the procedure

Title

Colon Area Screened

Description

Subjective evaluation of the additional area screened by the physician.

Time Frame

During the procedure

Title

Patient Satisfaction

Description

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

Time Frame

24 hours post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: