Colorectal Neoplasms
Conditions
Keywords
Colorectal, Neoplasms, Adenomas, Polyps, Miss rates, Detection rates, Colonoscope, Third Eye Retroscope
Brief summary
The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone. Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first. Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.
Detailed description
Colonoscopy is generally agreed to be the best method for detecting and removing pre-cancerous polyps, but some lesions can be missed, especially if they are located behind folds in the lining of the colon or behind flexures (sharp bends) in the colon. The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon. Previous studies have shown the device to be effective for detecting additional polyps that could not have been seen with the colonoscope alone. The purpose of this research is to compare the additional diagnostic yield obtained by using the Third Eye® Retroscope® vs. the diagnostic yield for the standard colonoscope alone in the context of a randomized, controlled study design. Patients who are scheduled for colonoscopy will be recruited to the study and randomized to one of two groups. Each patient will undergo two back-to-back procedures. Patients in Group A (study group) will undergo a standard colonoscopy followed immediately by a Third Eye colonoscopy. Patients in Group B (control group) will undergo a Third Eye colonoscopy followed immediately by a standard colonoscopy. Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.
Interventions
DEVICEThird Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon
Sponsors
Avantis Medical Systems
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; * The patient must understand and provide written consent for the procedure.
Exclusion criteria
* Patients with a history of colonic resection; * Patients with inflammatory bowel disease; * Patients with a personal history of polyposis syndrome; * Patients with suspected chronic stricture potentially precluding complete colonoscopy; * Patients with diverticulitis or toxic megacolon; * Patients with a history of radiation therapy to abdomen or pelvis; * Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rates for Adenomas and for Total Polyps | Acute - subjects were followed for the duration of the procedures, an average of 40 minutes. | Numbers of polyps and adenomas detected in first and second procedures for each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Times for Withdrawal Phase and for Complete Procedure | Acute - subjects were followed for the duration of the procedures, an average of 40 minutes. | For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure |
Countries
Belgium, Italy, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 184 |
| 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 | 188 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inability to reach cecum | 5 | 2 |
| Overall Study | Inadequate bowel preparation | 11 | 17 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 5 | 3 |
| Overall Study | Protocol Violation | 11 | 12 |
| Overall Study | Technical error or malfunction | 15 | 14 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group A - SC Followed by TEC | Group B - TEC Followed by SC | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 9.8 | 58.0 years STANDARD_DEVIATION 9.7 | 57.8 years STANDARD_DEVIATION 9.7 |
| Indication for colonoscopy procedure Diagnostic | 46 participants in ITT population | 41 participants in ITT population | 87 participants in ITT population |
| Indication for colonoscopy procedure Screening | 97 participants in ITT population | 92 participants in ITT population | 189 participants in ITT population |
| Indication for colonoscopy procedure Surveillance | 41 participants in ITT population | 55 participants in ITT population | 96 participants in ITT population |
| Region of Enrollment Belgium | 24 participants in ITT population | 26 participants in ITT population | 50 participants in ITT population |
| Region of Enrollment Italy | 25 participants in ITT population | 28 participants in ITT population | 53 participants in ITT population |
| Region of Enrollment Netherlands | 19 participants in ITT population | 22 participants in ITT population | 41 participants in ITT population |
| Region of Enrollment United Kingdom | 2 participants in ITT population | 1 participants in ITT population | 3 participants in ITT population |
| Region of Enrollment United States | 114 participants in ITT population | 111 participants in ITT population | 225 participants in ITT population |
| Sex: Female, Male Female | 69 Participants | 59 Participants | 128 Participants |
| Sex: Female, Male Male | 115 Participants | 129 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 184 | 0 / 188 |
| serious Total, serious adverse events | 0 / 184 | 0 / 188 |
Outcome results
Primary
Detection Rates for Adenomas and for Total Polyps
Numbers of polyps and adenomas detected in first and second procedures for each group
Time frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
Population: Per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - SC Followed by TEC | Detection Rates for Adenomas and for Total Polyps | Polyps detected in first procedure | 160 Polyps or adenomas detected |
| Group A - SC Followed by TEC | Detection Rates for Adenomas and for Total Polyps | Polyps detected in second procedure | 78 Polyps or adenomas detected |
| Group A - SC Followed by TEC | Detection Rates for Adenomas and for Total Polyps | Adenomas detected in first procedure | 107 Polyps or adenomas detected |
| Group A - SC Followed by TEC | Detection Rates for Adenomas and for Total Polyps | Adenomas detected in second procedure | 49 Polyps or adenomas detected |
| Group B - TEC Followed by SC | Detection Rates for Adenomas and for Total Polyps | Adenomas detected in second procedure | 26 Polyps or adenomas detected |
| Group B - TEC Followed by SC | Detection Rates for Adenomas and for Total Polyps | Polyps detected in first procedure | 163 Polyps or adenomas detected |
| Group B - TEC Followed by SC | Detection Rates for Adenomas and for Total Polyps | Adenomas detected in first procedure | 115 Polyps or adenomas detected |
| Group B - TEC Followed by SC | Detection Rates for Adenomas and for Total Polyps | Polyps detected in second procedure | 31 Polyps or adenomas detected |
Secondary
Times for Withdrawal Phase and for Complete Procedure
For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - SC Followed by TEC | Times for Withdrawal Phase and for Complete Procedure | Mean withdrawal time | 7.58 Minutes | Standard Deviation 2.79 |
| Group A - SC Followed by TEC | Times for Withdrawal Phase and for Complete Procedure | Mean total procedure time | 16.97 Minutes | Standard Deviation 9.9 |
| Group B - TEC Followed by SC | Times for Withdrawal Phase and for Complete Procedure | Mean withdrawal time | 9.52 Minutes | Standard Deviation 6.15 |
| Group B - TEC Followed by SC | Times for Withdrawal Phase and for Complete Procedure | Mean total procedure time | 20.87 Minutes | Standard Deviation 10.06 |