Trial Outcomes & Findings for Third Eye Retroscope Randomized Clinical Evaluation (NCT NCT01044732)
NCT ID: NCT01044732
Last Updated: 2017-07-25
Results Overview
Numbers of polyps and adenomas detected in first and second procedures for each group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
448 participants
Primary outcome timeframe
Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
Results posted on
2017-07-25
Participant Flow
Participant milestones
| Measure |
Group A - SC Followed by TEC
Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
Group B - TEC Followed by SC
Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
226
|
|
Overall Study
COMPLETED
|
173
|
176
|
|
Overall Study
NOT COMPLETED
|
49
|
50
|
Reasons for withdrawal
| Measure |
Group A - SC Followed by TEC
Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
Group B - TEC Followed by SC
Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
5
|
3
|
|
Overall Study
Protocol Violation
|
11
|
12
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Inadequate bowel preparation
|
11
|
17
|
|
Overall Study
Inability to reach cecum
|
5
|
2
|
|
Overall Study
Technical error or malfunction
|
15
|
14
|
Baseline Characteristics
Third Eye Retroscope Randomized Clinical Evaluation
Baseline characteristics by cohort
| Measure |
Group A - SC Followed by TEC
n=184 Participants
Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
Group B - TEC Followed by SC
n=188 Participants
Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
19 participants in ITT population
n=5 Participants
|
22 participants in ITT population
n=7 Participants
|
41 participants in ITT population
n=5 Participants
|
|
Region of Enrollment
Belgium
|
24 participants in ITT population
n=5 Participants
|
26 participants in ITT population
n=7 Participants
|
50 participants in ITT population
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants in ITT population
n=5 Participants
|
111 participants in ITT population
n=7 Participants
|
225 participants in ITT population
n=5 Participants
|
|
Region of Enrollment
Italy
|
25 participants in ITT population
n=5 Participants
|
28 participants in ITT population
n=7 Participants
|
53 participants in ITT population
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants in ITT population
n=5 Participants
|
1 participants in ITT population
n=7 Participants
|
3 participants in ITT population
n=5 Participants
|
|
Indication for colonoscopy procedure
Screening
|
97 participants in ITT population
n=5 Participants
|
92 participants in ITT population
n=7 Participants
|
189 participants in ITT population
n=5 Participants
|
|
Indication for colonoscopy procedure
Surveillance
|
41 participants in ITT population
n=5 Participants
|
55 participants in ITT population
n=7 Participants
|
96 participants in ITT population
n=5 Participants
|
|
Indication for colonoscopy procedure
Diagnostic
|
46 participants in ITT population
n=5 Participants
|
41 participants in ITT population
n=7 Participants
|
87 participants in ITT population
n=5 Participants
|
PRIMARY outcome
Timeframe: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.Population: Per-protocol population
Numbers of polyps and adenomas detected in first and second procedures for each group
Outcome measures
| Measure |
Group A - SC Followed by TEC
n=173 Participants
Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
Group B - TEC Followed by SC
n=176 Participants
Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
|---|---|---|
|
Detection Rates for Adenomas and for Total Polyps
Polyps detected in first procedure
|
160 Polyps or adenomas detected
|
163 Polyps or adenomas detected
|
|
Detection Rates for Adenomas and for Total Polyps
Polyps detected in second procedure
|
78 Polyps or adenomas detected
|
31 Polyps or adenomas detected
|
|
Detection Rates for Adenomas and for Total Polyps
Adenomas detected in first procedure
|
107 Polyps or adenomas detected
|
115 Polyps or adenomas detected
|
|
Detection Rates for Adenomas and for Total Polyps
Adenomas detected in second procedure
|
49 Polyps or adenomas detected
|
26 Polyps or adenomas detected
|
SECONDARY outcome
Timeframe: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.Population: All subjects in study (i.e., Group A and Group B combined)
For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure
Outcome measures
| Measure |
Group A - SC Followed by TEC
n=349 Participants
Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
Group B - TEC Followed by SC
n=349 Participants
Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon
|
|---|---|---|
|
Times for Withdrawal Phase and for Complete Procedure
Mean withdrawal time
|
7.58 Minutes
Standard Deviation 2.79
|
9.52 Minutes
Standard Deviation 6.15
|
|
Times for Withdrawal Phase and for Complete Procedure
Mean total procedure time
|
16.97 Minutes
Standard Deviation 9.90
|
20.87 Minutes
Standard Deviation 10.06
|
Adverse Events
Group A - SC Followed by TEC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B - TEC Followed by SC
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
Jack Higgins, MD - Chief Medical Officer
Avantis Medical Systems
Phone: 6508239216
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place