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Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

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ClinicalTrials.gov Identifier: NCT03807089
Recruitment Status : Completed
First Posted : January 16, 2019
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Pentax Medical
Information provided by (Responsible Party):
Norman Nishioka, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Colonoscopy
Interventions Device: Conventional Pediatric Colonoscope
Device: Short-Turn Radius Colonoscope
Enrollment 283
Recruitment Details  
Pre-assignment Details 89 subjects were excluded (poor bowel preparation [n = 45], prior colonic resection [n = 3], difficult first insertion [n=45], not over 40 [n = 1], no history of adenomatous colorectal polyps [n = 1], device related reasons [n = 1])
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Hide Arm/Group Description

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

Period Title: Overall Study
Started 101 93
Completed 101 93
Not Completed 0 0
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope Total
Hide Arm/Group Description

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

Total of all reporting groups
Overall Number of Baseline Participants 101 93 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 93 participants 194 participants
66.2  (8.13) 65.8  (8.38) 65.9  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 93 participants 194 participants
Female
59
  58.4%
59
  63.4%
118
  60.8%
Male
42
  41.6%
34
  36.6%
76
  39.2%
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 101 participants 93 participants 194 participants
101 93 194
1.Primary Outcome
Title Percentage of Patients With At Least One Adenoma
Hide Description Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Hide Arm/Group Description:

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

Overall Number of Participants Analyzed 101 93
Measure Type: Count of Participants
Unit of Measure: Participants
63
  62.4%
68
  73.1%
2.Secondary Outcome
Title Overall Polyp Detection Rate
Hide Description Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Hide Arm/Group Description:

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

Overall Number of Participants Analyzed 101 93
Measure Type: Count of Participants
Unit of Measure: Participants
72
  71.3%
78
  83.9%
3.Secondary Outcome
Title Mean Number of Adenomas Identified Per Patient With Polyps
Hide Description Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Hide Arm/Group Description:

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

Overall Number of Participants Analyzed 101 93
Mean (Standard Deviation)
Unit of Measure: Number of Adenomas Per Patient
2.48  (2.05) 2.50  (1.56)
4.Other Pre-specified Outcome
Title Size of Polyps Detected
Hide Description Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Hide Arm/Group Description:

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

Overall Number of Participants Analyzed 101 93
Mean (Standard Deviation)
Unit of Measure: mm
4.89  (2.92) 4.50  (2.30)
5.Other Pre-specified Outcome
Title Size of Adenomas Detected
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Hide Arm/Group Description:

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

Overall Number of Participants Analyzed 101 93
Mean (Standard Deviation)
Unit of Measure: mm
5.15  (3.04) 4.69  (2.40)
Time Frame Adverse events data were collected during the procedure, an average of 1 hour.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Hide Arm/Group Description

Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Short-Turn Radius Colonoscope

Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

Conventional Pediatric Colonoscope

All-Cause Mortality
Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/93 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/93 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Short-Turn Radius Colonoscope Conventional Pediatric Colonoscope
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/93 (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. Norman Nishioka
Organization: Massachusetts General Hospital
Phone: 617-726-4422
EMail: nnishioka@partners.org
Publications:
Layout table for additonal information
Responsible Party: Norman Nishioka, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03807089     History of Changes
Other Study ID Numbers: 2014P000677
First Submitted: January 11, 2019
First Posted: January 16, 2019
Results First Submitted: May 29, 2019
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019