Trial Outcomes & Findings for Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study (NCT NCT01955122)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

126 participants

Primary outcome timeframe

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

Results posted on

2017-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group A Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.	Group B Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
Overall Study STARTED	64	62
Overall Study No.Patients Enrolled	64	62
Overall Study No. Patients Completed Double Procedure	59	57
Overall Study COMPLETED	59	57
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.	Group B Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
Overall Study Physician Decision	5	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=59 Participants Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.	Group B n=57 Participants Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device) .	Total n=116 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=93 Participants	40 Participants n=4 Participants	80 Participants n=27 Participants
Age, Categorical >=65 years	19 Participants n=93 Participants	17 Participants n=4 Participants	36 Participants n=27 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 9.3 • n=93 Participants	57.9 years STANDARD_DEVIATION 9.1 • n=4 Participants	58.7 years STANDARD_DEVIATION 9.2 • n=27 Participants
Gender Female	29 Participants n=93 Participants	16 Participants n=4 Participants	45 Participants n=27 Participants
Gender Male	30 Participants n=93 Participants	41 Participants n=4 Participants	71 Participants n=27 Participants
Region of Enrollment Netherlands	34 participants n=93 Participants	36 participants n=4 Participants	70 participants n=27 Participants
Region of Enrollment United States	5 participants n=93 Participants	3 participants n=4 Participants	8 participants n=27 Participants
Region of Enrollment Israel	20 participants n=93 Participants	18 participants n=4 Participants	38 participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Group A n=59 Participants Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.	Group B n=57 Participants Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
Adenoma and Polyp Miss Rate Adenoma Miss Rate	48.3 percentage of :Adenomas/Polyp missed Interval 35.0 to 61.2	10.4 percentage of :Adenomas/Polyp missed Interval 2.9 to 18.0
Adenoma and Polyp Miss Rate Polyp Miss Rate	52.8 percentage of :Adenomas/Polyp missed Interval 43.2 to 62.0	9.1 percentage of :Adenomas/Polyp missed Interval 3.9 to 14.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group A n=59 Participants Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.	Group B n=57 Participants Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
Total Number of Therapeutic Interventions Performed	106 Total Interventions performed	121 Total Interventions performed

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Group A n=116 Participants Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.	Group B n=116 Participants Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
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 Total procedure time	21.6 minutes Standard Deviation 8.9	18.5 minutes Standard Deviation 8.2
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 to cecum	9.3 minutes Standard Deviation 7.3	8.4 minutes Standard Deviation 5.6
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 Withdrawal time	7.4 minutes Standard Deviation 1.9	7.2 minutes Standard Deviation 2.2

SECONDARY outcome

Timeframe: During the procedure

Population: Sedation dosage was not collected from any participant during the study

Sedation dosage

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the procedure

Population: Centering ability was not collected from any procedure during the study

Ability to center the scope inside the gastrointestinal tract.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the procedure

Population: Evaluation of the additional area screened by the physician was not collected from any participant during the study

Subjective evaluation of the additional area screened by the physician.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours post procedure

Population: Data was not analyzed since the patients satisfactory score was general estimation which could not be associated with either the standard colonoscopy or the EndoRings colonoscopy, therefore the intended endpoint failed.

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

Outcome measures

Outcome data not reported

Adverse Events

A (Study Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B (Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Peter Siersema

UMC Utrecht

Phone: +31 88 7559338

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60