Trial Outcomes & Findings for A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy (NCT NCT02345889)
NCT ID: NCT02345889
Last Updated: 2019-03-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1262 participants
Primary outcome timeframe
During Procedure
Results posted on
2019-03-12
Participant Flow
Participant milestones
| Measure |
Standard Colonoscopy
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
316
|
316
|
315
|
315
|
|
Overall Study
COMPLETED
|
295
|
299
|
295
|
299
|
|
Overall Study
NOT COMPLETED
|
21
|
17
|
20
|
16
|
Reasons for withdrawal
| Measure |
Standard Colonoscopy
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Overall Study
Inadequate Bowel Prep
|
17
|
16
|
18
|
14
|
|
Overall Study
Polyposis identified during procedure
|
1
|
1
|
0
|
1
|
|
Overall Study
Recognized ineligible post-randomization
|
1
|
0
|
2
|
1
|
|
Overall Study
Ulcerative Colitis identified
|
1
|
0
|
0
|
0
|
|
Overall Study
Cecum not intubated
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
Baseline characteristics by cohort
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
Total
n=1188 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
62.6 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
582 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
606 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
272 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
269 Participants
n=4 Participants
|
1093 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Indication
Screening
|
127 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
504 Participants
n=21 Participants
|
|
Indication
Surveillance
|
151 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
607 Participants
n=21 Participants
|
|
Indication
Diagnostic
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Indication
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During ProcedurePopulation: The number of adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Adenomas Per Colonoscopy
All Sites
|
1.53 Adenomas per Colonoscopy
Standard Deviation 2.33
|
1.82 Adenomas per Colonoscopy
Standard Deviation 2.58
|
1.55 Adenomas per Colonoscopy
Standard Deviation 2.42
|
1.30 Adenomas per Colonoscopy
Standard Deviation 1.96
|
|
Adenomas Per Colonoscopy
Indianapolis
|
1.89 Adenomas per Colonoscopy
Standard Deviation 2.69
|
2.17 Adenomas per Colonoscopy
Standard Deviation 2.88
|
1.97 Adenomas per Colonoscopy
Standard Deviation 2.77
|
1.59 Adenomas per Colonoscopy
Standard Deviation 2.18
|
|
Adenomas Per Colonoscopy
Milan
|
0.83 Adenomas per Colonoscopy
Standard Deviation 1.18
|
0.80 Adenomas per Colonoscopy
Standard Deviation 1.25
|
0.72 Adenomas per Colonoscopy
Standard Deviation 1.17
|
0.68 Adenomas per Colonoscopy
Standard Deviation 1.19
|
|
Adenomas Per Colonoscopy
New York
|
0.92 Adenomas per Colonoscopy
Standard Deviation 1.15
|
2.00 Adenomas per Colonoscopy
Standard Deviation 2.34
|
0.75 Adenomas per Colonoscopy
Standard Deviation 0.94
|
0.80 Adenomas per Colonoscopy
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The number of participants with detected adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Number of Participants With Detected Adenoma
All Sites
|
166 Participants
|
191 Participants
|
167 Participants
|
154 Participants
|
|
Number of Participants With Detected Adenoma
Indianapolis
|
117 Participants
|
137 Participants
|
127 Participants
|
115 Participants
|
|
Number of Participants With Detected Adenoma
Milan
|
37 Participants
|
35 Participants
|
29 Participants
|
28 Participants
|
|
Number of Participants With Detected Adenoma
New York
|
12 Participants
|
19 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The number of participants analyzed differed because the calculation was done for all three sites overall and then broken down into each specific site. Thus, only patients randomized to the treatment arm at that site were included in the specific site calculations instead of including the total number of patients randomized to that treatment arm.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Percentage of Participants With Detected Adenoma
All Sites
|
56 Percentage of Participants
|
64 Percentage of Participants
|
57 Percentage of Participants
|
52 Percentage of Participants
|
|
Percentage of Participants With Detected Adenoma
Indianapolis
|
61 Percentage of Participants
|
70 Percentage of Participants
|
65 Percentage of Participants
|
58 Percentage of Participants
|
|
Percentage of Participants With Detected Adenoma
Milan
|
47 Percentage of Participants
|
47 Percentage of Participants
|
39 Percentage of Participants
|
37 Percentage of Participants
|
|
Percentage of Participants With Detected Adenoma
New York
|
48 Percentage of Participants
|
68 Percentage of Participants
|
46 Percentage of Participants
|
44 Percentage of Participants
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The number of sessile serrated polyps per colonoscopy was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Sessile Serrated Polyps Per Colonoscopy
All Sites
|
0.17 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.54
|
0.17 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.54
|
0.20 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.81
|
0.18 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.74
|
|
Sessile Serrated Polyps Per Colonoscopy
Indianapolis
|
0.24 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.64
|
0.23 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.63
|
0.29 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.98
|
0.25 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.89
|
|
Sessile Serrated Polyps Per Colonoscopy
Milan
|
0.03 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.16
|
0.04 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.26
|
0.01 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.12
|
0.03 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.16
|
|
Sessile Serrated Polyps Per Colonoscopy
New York
|
0.04 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.20
|
0.07 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.26
|
0.04 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.20
|
0.04 Sessile Serrated Polyps per colonoscopy
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The number of participants with detected sessile serrated polyps was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
Number of patients with 1 or more sessile serrated polyps
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Number of Participants With Detected Sessile Serrated Polyp
All Sites
|
36 Participants
|
33 Participants
|
33 Participants
|
30 Participants
|
|
Number of Participants With Detected Sessile Serrated Polyp
Indianapolis
|
33 Participants
|
29 Participants
|
31 Participants
|
27 Participants
|
|
Number of Participants With Detected Sessile Serrated Polyp
Milan
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Detected Sessile Serrated Polyp
New York
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The number of participants analyzed for each site differed because the percentage of patients with a sessile serrated polyp was calculated specifically for the site. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Percentage of Participants With Detected Sessile Serrated Polyp
All Sites
|
12 Percentage of Participants
|
11 Percentage of Participants
|
11 Percentage of Participants
|
10 Percentage of Participants
|
|
Percentage of Participants With Detected Sessile Serrated Polyp
Indianapolis
|
17 Percentage of Participants
|
15 Percentage of Participants
|
16 Percentage of Participants
|
14 Percentage of Participants
|
|
Percentage of Participants With Detected Sessile Serrated Polyp
Milan
|
3 Percentage of Participants
|
3 Percentage of Participants
|
1 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With Detected Sessile Serrated Polyp
New York
|
4 Percentage of Participants
|
7 Percentage of Participants
|
4 Percentage of Participants
|
4 Percentage of Participants
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The number of participants with a detected polyp was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Number of Participants With a Detected Polyp
All Sites
|
226 Participants
|
247 Participants
|
231 Participants
|
212 Participants
|
|
Number of Participants With a Detected Polyp
Indianapolis
|
162 Participants
|
175 Participants
|
171 Participants
|
155 Participants
|
|
Number of Participants With a Detected Polyp
Milan
|
46 Participants
|
50 Participants
|
42 Participants
|
38 Participants
|
|
Number of Participants With a Detected Polyp
New York
|
18 Participants
|
22 Participants
|
18 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The number of participants analyzed for each site differed because the percentage of patients with a polyp was calculated for each site specifically. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Percentage of Participants With a Detected Polyp
All Sites
|
77 Percentage of Participants
|
83 Percentage of Participants
|
78 Percentage of Participants
|
71 Percentage of Participants
|
|
Percentage of Participants With a Detected Polyp
Indianapolis
|
84 Percentage of Participants
|
89 Percentage of Participants
|
87 Percentage of Participants
|
78 Percentage of Participants
|
|
Percentage of Participants With a Detected Polyp
Milan
|
59 Percentage of Participants
|
68 Percentage of Participants
|
56 Percentage of Participants
|
51 Percentage of Participants
|
|
Percentage of Participants With a Detected Polyp
New York
|
72 Percentage of Participants
|
79 Percentage of Participants
|
75 Percentage of Participants
|
76 Percentage of Participants
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The mean insertion time was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Cecal Insertion Time
All Sites
|
422 Seconds
Standard Deviation 319
|
354 Seconds
Standard Deviation 216
|
403 Seconds
Standard Deviation 263
|
468 Seconds
Standard Deviation 311
|
|
Cecal Insertion Time
Indianapolis
|
366 Seconds
Standard Deviation 243
|
320 Seconds
Standard Deviation 179
|
352 Seconds
Standard Deviation 191
|
395 Seconds
Standard Deviation 225
|
|
Cecal Insertion Time
Milan
|
642 Seconds
Standard Deviation 405
|
503 Seconds
Standard Deviation 254
|
581 Seconds
Standard Deviation 356
|
731 Seconds
Standard Deviation 385
|
|
Cecal Insertion Time
New York
|
170 Seconds
Standard Deviation 62
|
193 Seconds
Standard Deviation 93
|
251 Seconds
Standard Deviation 110
|
242 Seconds
Standard Deviation 80
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: Gastroenterology fellows were allowed to assist in inserting the scope, but times included in this analysis were from insertions done completely by the physician. This is why the overall number analyzed differs from the number analyzed in other outcome measure as well as why the numbers differ depending on site and randomization arm.
Outcome measures
| Measure |
Standard Colonoscopy
n=173 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=169 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=173 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=176 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
All Sites
|
320 Seconds
Standard Deviation 256
|
265 Seconds
Standard Deviation 173
|
331 Seconds
Standard Deviation 222
|
380 Seconds
Standard Deviation 252
|
|
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
Indianapolis
|
283 Seconds
Standard Deviation 185
|
239 Seconds
Standard Deviation 127
|
277 Seconds
Standard Deviation 127
|
340 Seconds
Standard Deviation 169
|
|
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
Milan
|
556 Seconds
Standard Deviation 378
|
438 Seconds
Standard Deviation 269
|
588 Seconds
Standard Deviation 345
|
718 Seconds
Standard Deviation 401
|
|
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
New York
|
170 Seconds
Standard Deviation 62
|
193 Seconds
Standard Deviation 93
|
251 Seconds
Standard Deviation 110
|
242 Seconds
Standard Deviation 80
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The mean inspection time of all three sites overall was calculated as well as the mean inspection time for each individual site. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
Outcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Inspection Time
All Sites
|
444 Seconds
Standard Deviation 103
|
419 Seconds
Standard Deviation 95
|
417 Seconds
Standard Deviation 147
|
421 Seconds
Standard Deviation 112
|
|
Inspection Time
Indianapolis
|
418 Seconds
Standard Deviation 91
|
392 Seconds
Standard Deviation 89
|
388 Seconds
Standard Deviation 160
|
378 Seconds
Standard Deviation 83
|
|
Inspection Time
Milan
|
501 Seconds
Standard Deviation 109
|
492 Seconds
Standard Deviation 78
|
484 Seconds
Standard Deviation 92
|
522 Seconds
Standard Deviation 120
|
|
Inspection Time
New York
|
467 Seconds
Standard Deviation 95
|
414 Seconds
Standard Deviation 84
|
438 Seconds
Standard Deviation 96
|
454 Seconds
Standard Deviation 81
|
SECONDARY outcome
Timeframe: During ProcedureOutcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
All
|
205 Adenomas
|
253 Adenomas
|
213 Adenomas
|
194 Adenomas
|
|
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
1-5mm
|
160 Adenomas
|
199 Adenomas
|
162 Adenomas
|
145 Adenomas
|
|
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
6-9mm
|
28 Adenomas
|
37 Adenomas
|
31 Adenomas
|
35 Adenomas
|
|
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
greater than or equal to 10mm
|
17 Adenomas
|
17 Adenomas
|
20 Adenomas
|
14 Adenomas
|
SECONDARY outcome
Timeframe: During ProcedureOutcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
1-5mm
|
78 Percentage of Adenomas
|
79 Percentage of Adenomas
|
76 Percentage of Adenomas
|
75 Percentage of Adenomas
|
|
Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
6-9mm
|
14 Percentage of Adenomas
|
15 Percentage of Adenomas
|
15 Percentage of Adenomas
|
18 Percentage of Adenomas
|
|
Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
greater than or equal to 10mm
|
7 Percentage of Adenomas
|
7 Percentage of Adenomas
|
9 Percentage of Adenomas
|
7 Percentage of Adenomas
|
SECONDARY outcome
Timeframe: During ProcedureOutcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
All
|
20 Sessile Serrated Polyps
|
32 Sessile Serrated Polyps
|
29 Sessile Serrated Polyps
|
25 Sessile Serrated Polyps
|
|
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
1-5mm
|
9 Sessile Serrated Polyps
|
11 Sessile Serrated Polyps
|
8 Sessile Serrated Polyps
|
9 Sessile Serrated Polyps
|
|
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
6-9mm
|
6 Sessile Serrated Polyps
|
10 Sessile Serrated Polyps
|
8 Sessile Serrated Polyps
|
4 Sessile Serrated Polyps
|
|
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
greater than or equal to 10mm
|
5 Sessile Serrated Polyps
|
11 Sessile Serrated Polyps
|
13 Sessile Serrated Polyps
|
12 Sessile Serrated Polyps
|
SECONDARY outcome
Timeframe: During ProcedureOutcome measures
| Measure |
Standard Colonoscopy
n=295 Participants
A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy
|
Colonoscopy With EndoCuff™
n=299 Participants
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
|
Colonoscopy With EndoRings™
n=295 Participants
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
|
FUSE® Colonoscopy
n=299 Participants
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system
|
|---|---|---|---|---|
|
Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
greater than or equal to 10mm
|
25 Percentage of Sessile Serrated Polyps
|
34 Percentage of Sessile Serrated Polyps
|
45 Percentage of Sessile Serrated Polyps
|
48 Percentage of Sessile Serrated Polyps
|
|
Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
1-5mm
|
45 Percentage of Sessile Serrated Polyps
|
34 Percentage of Sessile Serrated Polyps
|
28 Percentage of Sessile Serrated Polyps
|
36 Percentage of Sessile Serrated Polyps
|
|
Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
6-9mm
|
30 Percentage of Sessile Serrated Polyps
|
31 Percentage of Sessile Serrated Polyps
|
28 Percentage of Sessile Serrated Polyps
|
16 Percentage of Sessile Serrated Polyps
|
Adverse Events
Standard Colonoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colonoscopy With EndoCuff™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colonoscopy With EndoRings™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FUSE® Colonoscopy
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