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

• Sponsor: EndoAid (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01955122
• Collaborator: (none)
• Enrollment: 126
• Locations: 3
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 42
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Device: Tandem Colonoscopy	N/A

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 Design

• Study Type: Interventional
• 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: Jul 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adenoma and Polyp Miss Rate [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 [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 [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 [During the procedure]

   Sedation dosage

4. Scope Centering Ability [During the procedure]

   Ability to center the scope inside the gastrointestinal tract.

5. Colon Area Screened [During the procedure]

   Subjective evaluation of the additional area screened by the physician.

6. Patient Satisfaction [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202
2	Elisha Medical Center	Haifa	Please Select	Israel	34601
3	University Medical Center Utrecht	Utrecht		Netherlands

Sponsors and Collaborators

• EndoAid

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EndoAid
• ClinicalTrials.gov Identifier: NCT01955122
• Other Study ID Numbers: TSDPR100
• First Posted: Oct 7, 2013
• Last Update Posted: Mar 6, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by EndoAid: polyp/adenoma miss rate; colonoscopy add-on device; enhanced screening
• Additional relevant MeSH terms: Colonic Neoplasms; Polyps

Study Results

Participant Flow

Arm/Group Title	Group A	Group B
Arm/Group 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.
Period Title: Overall Study
STARTED	64	62
No.Patients Enrolled	64	62
No. Patients Completed Double Procedure	59	57
COMPLETED	59	57
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Group A	Group B	Total
Arm/Group Description	Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.	Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device) .	Total of all reporting groups
Overall Participants	59	57	116
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	40 67.8%	40 70.2%	80 69%
>=65 years	19 32.2%	17 29.8%	36 31%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.6 (9.3)	57.9 (9.1)	58.7 (9.2)
Gender (Count of Participants)
Female	29 49.2%	16 28.1%	45 38.8%
Male	30 50.8%	41 71.9%	71 61.2%
Region of Enrollment (participants) [Number]
Netherlands	34 57.6%	36 63.2%	70 60.3%
United States	5 8.5%	3 5.3%	8 6.9%
Israel	20 33.9%	18 31.6%	38 32.8%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group 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.
Measure Participants	59	57
Adenoma Miss Rate	48.3	10.4
Polyp Miss Rate	52.8	9.1

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group 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.
Measure Participants	59	57
Number [Total Interventions performed]	106	121

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Standard Colonoscopy
Arm/Group Description	procedures performed with the EndoRings	procedures performed with the Standard
Measure Participants	116	116
Total procedure time	21.6 (8.9)	18.5 (8.2)
Time to cecum	9.3 (7.3)	8.4 (5.6)
Withdrawal time	7.4 (1.9)	7.2 (2.2)

4. Secondary Outcome

Title	Sedation
Description	Sedation dosage
Time Frame	During the procedure

Outcome Measure Data

Analysis Population Description

Sedation dosage was not collected from any participant during the study

Arm/Group Title	Group A	Group B
Arm/Group Description	Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.	Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
Measure Participants	0	0

5. Secondary Outcome

Title	Scope Centering Ability
Description	Ability to center the scope inside the gastrointestinal tract.
Time Frame	During the procedure

Outcome Measure Data

Analysis Population Description

Centering ability was not collected from any procedure during the study

Arm/Group Title	Group A	Group B
Arm/Group 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 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.	Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy. 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.
Measure Participants	0	0

6. Secondary Outcome

Title	Colon Area Screened
Description	Subjective evaluation of the additional area screened by the physician.
Time Frame	During the procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group A	Group B
Arm/Group 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.
Measure Participants	0	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group A	Group B
Arm/Group 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.
Measure Participants	0	0

Adverse Events

Time Frame	24 hours post procedure
Adverse Event Reporting Description	Serious or Other (non-serious) Adverse Events were monitored/assessed, but none were observed
Arm/Group Title	A (Study Group)		Group B (Control Group)
Arm/Group Description	Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.		Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
All Cause Mortality
	A (Study Group)		Group B (Control Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	A (Study Group)		Group B (Control Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	A (Study Group)		Group B (Control Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/57 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.