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Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps? (CAP Trial) (CAP)

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ClinicalTrials.gov Identifier: NCT01935180
Recruitment Status : Completed
First Posted : September 4, 2013
Results First Posted : May 30, 2017
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Adenomatous Polyps
Intervention Device: Colonoscopy Cap
Enrollment 1148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description Standard colonoscopy without an attachment cap

A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.

Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope.

Period Title: Overall Study
Started 573 575
Completed 552 561
Not Completed 21 14
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy Total
Hide Arm/Group Description Standard colonoscopy without an attachment cap

A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.

Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope.

Total of all reporting groups
Overall Number of Baseline Participants 552 561 1113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 552 participants 561 participants 1113 participants
61.5  (8.4) 62.5  (8.3) 61.8  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 552 participants 561 participants 1113 participants
Female
209
  37.9%
195
  34.8%
404
  36.3%
Male
343
  62.1%
366
  65.2%
709
  63.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 552 participants 561 participants 1113 participants
552 561 1113
Indication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 552 participants 561 participants 1113 participants
Colonoscopy performed for cancer screening
291
  52.7%
292
  52.0%
583
  52.4%
Colonoscopy performed for polyp surveillance
168
  30.4%
171
  30.5%
339
  30.5%
Colonoscopy performed for symptoms (diagnostic)
93
  16.8%
98
  17.5%
191
  17.2%
1.Primary Outcome
Title Mean Number of Adenomas
Hide Description Mean number of adenomas per patient in each group.
Time Frame duration of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description:
Colonoscopy without a cap.
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Overall Number of Participants Analyzed 552 561
Mean (Standard Deviation)
Unit of Measure: adenoma per patient
0.82  (1.5) 0.89  (1.6)
2.Secondary Outcome
Title Adenoma Detection Rate
Hide Description • Adenoma detection rate (ADR), % of patients with at least 1 adenoma
Time Frame duration of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description:
Colonoscopy without a cap.
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Overall Number of Participants Analyzed 552 561
Measure Type: Count of Participants
Unit of Measure: Participants
219
  39.7%
235
  41.9%
3.Secondary Outcome
Title Advanced Adenoma Detection Rate
Hide Description Proportion of patients with advanced adenomas
Time Frame duration of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description:
Colonoscopy without a cap.
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Overall Number of Participants Analyzed 552 561
Measure Type: Count of Participants
Unit of Measure: Participants
49
   8.9%
55
   9.8%
4.Secondary Outcome
Title Quality of Bowel Preparation
Hide Description Proportion of patients with a bowel preparation that was rated as good or excellent (four point scale that distinguishes the bowel prep as poor, fair, good or excellent).
Time Frame duration of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description:
Colonoscopy without a cap.
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Overall Number of Participants Analyzed 552 561
Measure Type: Count of Participants
Unit of Measure: Participants
518
  93.8%
502
  89.5%
5.Secondary Outcome
Title Withdrawal Time
Hide Description • Time taken for the withdrawal of the colonoscope from the cecum to anus among patients, who did not have any polyps.
Time Frame time of colonoscope withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description:
Colonoscopy without a cap.
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Overall Number of Participants Analyzed 552 561
Median (Inter-Quartile Range)
Unit of Measure: minutes
8.9
(7.4 to 11.2)
8.4
(6.7 to 10.2)
6.Secondary Outcome
Title Ease of Terminal Ileum Intubation
Hide Description • Proportion of patients, for whom intubation of the terminal ileum with the colonoscope was rated as "easy". Intubation could be rated by the endoscopist as "easy", "slightly difficult", "difficult", or "unable to intubate".
Time Frame during colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description:
Colonoscopy without a cap.
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Overall Number of Participants Analyzed 552 561
Measure Type: Count of Participants
Unit of Measure: Participants
435
  78.8%
473
  84.3%
7.Secondary Outcome
Title Real Time Prediction of Polyp Histology
Hide Description Difference in recommended surveillance interval between real time polyp diagnosis and pathological diagnosis among patients with at least one diminutive polyp
Time Frame duration of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description:
Colonoscopy without a cap.
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Overall Number of Participants Analyzed 269 297
Measure Type: Count of Participants
Unit of Measure: Participants
246
  91.4%
281
  94.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Colonoscopy Cap Assisted Colonoscopy
Hide Arm/Group Description Colonoscopy without a cap. A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
All-Cause Mortality
Standard Colonoscopy Cap Assisted Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Colonoscopy Cap Assisted Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/552 (0.00%)   0/561 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Colonoscopy Cap Assisted Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/552 (0.00%)   0/561 (0.00%) 
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. Heiko Pohl
Organization: VA Medical Center
Phone: 8022959362 ext 5595
EMail: heiko.pohl@dartmouth.edu
Layout table for additonal information
Responsible Party: Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01935180     History of Changes
Other Study ID Numbers: DMS-22424
First Submitted: January 19, 2012
First Posted: September 4, 2013
Results First Submitted: March 4, 2017
Results First Posted: May 30, 2017
Last Update Posted: September 25, 2018