Trial Outcomes & Findings for Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope (NCT NCT03807089)
NCT ID: NCT03807089
Last Updated: 2019-07-16
Results Overview
Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
283 participants
Primary outcome timeframe
1 hour
Results posted on
2019-07-16
Participant Flow
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 \[n = 1\])
Participant milestones
| Measure |
Short-Turn Radius Colonoscope
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 The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.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
|
Conventional Pediatric 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 The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.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 Study
STARTED
|
101
|
93
|
|
Overall Study
COMPLETED
|
101
|
93
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Short-Turn Radius Colonoscope
n=101 Participants
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 The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.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
|
Conventional Pediatric Colonoscope
n=93 Participants
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
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 8.13 • n=101 Participants
|
65.8 years
STANDARD_DEVIATION 8.38 • n=93 Participants
|
65.9 years
STANDARD_DEVIATION 8.2 • n=194 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=101 Participants
|
59 Participants
n=93 Participants
|
118 Participants
n=194 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=101 Participants
|
34 Participants
n=93 Participants
|
76 Participants
n=194 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
101 participants
n=101 Participants
|
93 participants
n=93 Participants
|
194 participants
n=194 Participants
|
PRIMARY outcome
Timeframe: 1 hourCompare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Outcome measures
| Measure |
Short-Turn Radius Colonoscope
n=101 Participants
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
|
Conventional Pediatric Colonoscope
n=93 Participants
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
|
|---|---|---|
|
Percentage of Patients With At Least One Adenoma
|
63 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 1 hourCompare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Outcome measures
| Measure |
Short-Turn Radius Colonoscope
n=101 Participants
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
|
Conventional Pediatric Colonoscope
n=93 Participants
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 Polyp Detection Rate
|
72 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 1 hourCompare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Outcome measures
| Measure |
Short-Turn Radius Colonoscope
n=101 Participants
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
|
Conventional Pediatric Colonoscope
n=93 Participants
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
|
|---|---|---|
|
Mean Number of Adenomas Identified Per Patient With Polyps
|
2.48 Number of Adenomas Per Patient
Standard Deviation 2.05
|
2.50 Number of Adenomas Per Patient
Standard Deviation 1.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 hourPolyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).
Outcome measures
| Measure |
Short-Turn Radius Colonoscope
n=101 Participants
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
|
Conventional Pediatric Colonoscope
n=93 Participants
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
|
|---|---|---|
|
Size of Polyps Detected
|
4.89 mm
Standard Deviation 2.92
|
4.50 mm
Standard Deviation 2.30
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 hourOutcome measures
| Measure |
Short-Turn Radius Colonoscope
n=101 Participants
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
|
Conventional Pediatric Colonoscope
n=93 Participants
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
|
|---|---|---|
|
Size of Adenomas Detected
|
5.15 mm
Standard Deviation 3.04
|
4.69 mm
Standard Deviation 2.40
|
Adverse Events
Short-Turn Radius Colonoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Pediatric Colonoscope
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place