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Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

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ClinicalTrials.gov Identifier: NCT02665741
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Colon Cancer Screening
Colon Polyps
Colon Adenomas
Water Exchange Colonoscopy
Interventions Device: Olympus transparent cap
Device: Medivators Endocuff
Device: Control
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Olympus Transparent Cap Medivators Endocuff
Hide Arm/Group Description

No distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

Period Title: Overall Study
Started 42 42 42
Completed 42 42 42
Not Completed 0 0 0
Arm/Group Title Control Olympus Transparent Cap Medivators Endocuff Total
Hide Arm/Group Description

No distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

Total of all reporting groups
Overall Number of Baseline Participants 42 42 42 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 42 participants 126 participants
59.3  (7.4) 60.0  (6.7) 60.0  (6.8) 60  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 126 participants
Female
19
  45.2%
18
  42.9%
19
  45.2%
56
  44.4%
Male
23
  54.8%
24
  57.1%
23
  54.8%
70
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 126 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   7.1%
1
   2.4%
2
   4.8%
6
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.4%
1
   2.4%
1
   2.4%
3
   2.4%
White
31
  73.8%
33
  78.6%
32
  76.2%
96
  76.2%
More than one race
5
  11.9%
2
   4.8%
6
  14.3%
13
  10.3%
Unknown or Not Reported
2
   4.8%
5
  11.9%
1
   2.4%
8
   6.3%
Smoking status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 126 participants
Never Smoker
30
  71.4%
24
  57.1%
28
  66.7%
82
  65.1%
Former Smoker
11
  26.2%
16
  38.1%
13
  31.0%
40
  31.7%
Current Smoker
1
   2.4%
2
   4.8%
1
   2.4%
4
   3.2%
Alcoholic drinks per week  
Mean (Standard Deviation)
Unit of measure:  Drinks per week
Number Analyzed 42 participants 42 participants 42 participants 126 participants
4.0  (3.6) 6.8  (10.7) 4.4  (4.0) 5.07  (6.97)
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 126 participants
4
   9.5%
3
   7.1%
5
  11.9%
12
   9.5%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 42 participants 42 participants 42 participants 126 participants
28.5  (4.3) 28.3  (5.5) 27.4  (5.4) 28.07  (5.08)
1.Primary Outcome
Title Adenoma Detection Rate
Hide Description The investigators will compare adenoma detection rate at completion of study across the 3 arms
Time Frame Completion of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Olympus Transparent Cap Medivators Endocuff
Hide Arm/Group Description:

No distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

Overall Number of Participants Analyzed 42 42 42
Measure Type: Number
Unit of Measure: percentage of adenomas detected
52.4 40.5 54.8
2.Secondary Outcome
Title Proximal Adenoma Detection Rate
Hide Description The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms
Time Frame Completion of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Olympus Transparent Cap Medivators Endocuff
Hide Arm/Group Description:

No distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

Overall Number of Participants Analyzed 42 42 42
Measure Type: Number
Unit of Measure: percentage of proximal adenomas
45.2 35.7 50.0
3.Secondary Outcome
Title Cecal Intubation Rate
Hide Description The investigators will compare cecal intubation rate at completion of study across the 3 arms
Time Frame Completion of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Olympus Transparent Cap Medivators Endocuff
Hide Arm/Group Description:

No distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

Overall Number of Participants Analyzed 42 42 42
Measure Type: Number
Unit of Measure: percentage of cecal intubation
100 100 100
4.Secondary Outcome
Title Withdrawal Time
Hide Description The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms
Time Frame Completion of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Olympus Transparent Cap Medivators Endocuff
Hide Arm/Group Description:

No distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: minutes
12.9  (5.2) 12.4  (5.6) 13.0  (6.2)
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Olympus Transparent Cap Medivators Endocuff
Hide Arm/Group Description

Standard colonoscopy - no distal colonoscope attachment will be used in this arm

Control: No distal colonoscope attachments

The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure

Olympus transparent cap: distal colonoscope attachment

The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure

Medivators Endocuff: distal colonoscope attachment

All-Cause Mortality
Control Olympus Transparent Cap Medivators Endocuff
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)      0/42 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
Control Olympus Transparent Cap Medivators Endocuff
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/42 (0.00%)      0/42 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Olympus Transparent Cap Medivators Endocuff
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/42 (0.00%)      2/42 (4.76%)    
Gastrointestinal disorders       
Bleeding  [1]  0/42 (0.00%)  0 0/42 (0.00%)  0 2/42 (4.76%)  2
Indicates events were collected by systematic assessment
[1]
Post polypectomy bleeding
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sooraj Tejaswi
Organization: University of California, Davis
Phone: 916-734-7215
EMail: stejaswi@ucdavis.edu
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02665741    
Other Study ID Numbers: 797109
First Submitted: January 25, 2016
First Posted: January 28, 2016
Results First Submitted: April 15, 2019
Results First Posted: June 18, 2020
Last Update Posted: June 18, 2020