An interventional study of Third Eye Retroscope in Colorectal Neoplasms, sponsored by Avantis Medical Systems. Completed at 9 sites in 5 countries. Per ClinicalTrials.gov, last updated 2017-07-25.
Sponsored by Avantis Medical Systems · Not applicable, Interventional, and Diagnostic
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 448 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Avantis Medical Systems is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Complete examination with standard colonoscope ("COLO") followed by complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope
Device: Third Eye Retroscope
Complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope ("COLO") alone
Device: Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon
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.
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.
| Milestone | Group A - SC Followed by TEC | Group B - TEC Followed by SC |
|---|---|---|
| Started | 222 | 226 |
| Completed | 173 | 176 |
| Not completed | 49 | 50 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Physician decision | 5 | 3 |
| Withdrew: Protocol violation | 11 | 12 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Inadequate bowel preparation | 11 | 17 |
| Withdrew: Inability to reach cecum | 5 | 2 |
| Withdrew: Technical error or malfunction | 15 | 14 |
Numbers of polyps and adenomas detected in first and second procedures for each group
| Polyps or adenomas detected | Group A - SC Followed by TEC | Group B - TEC Followed by SC |
|---|---|---|
| Polyps detected in first procedure | 160 | 163 |
| Polyps detected in second procedure | 78 | 31 |
| Adenomas detected in first procedure | 107 | 115 |
| Adenomas detected in second procedure | 49 | 26 |
For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure
| Minutes | All SC Procedures | All TEC Procedures |
|---|---|---|
| Mean withdrawal time | 7.58 ± 2.79 | 9.52 ± 6.15 |
| Mean total procedure time | 16.97 ± 9.90 | 20.87 ± 10.06 |
Collected over 24-72 hours post-procedure. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A - SC Followed by TEC | — | 0/184 (0%) | 0/184 (0%) |
| Group B - TEC Followed by SC | — | 0/188 (0%) | 0/188 (0%) |
Intention-to-treat population, i.e., those who were actually examined during the study
| Age, Continuous(years) | Group A - SC Followed by TEC | Group B - TEC Followed by SC | Total |
|---|---|---|---|
| Mean | 57.6 ± 9.8 | 58.0 ± 9.7 | 57.8 ± 9.7 |
| Sex: Female, Male(Participants) | Group A - SC Followed by TEC | Group B - TEC Followed by SC | Total |
|---|---|---|---|
| Female | 69 | 59 | 128 |
| Male | 115 | 129 | 244 |
| Region of Enrollment(participants in ITT population) | Group A - SC Followed by TEC | Group B - TEC Followed by SC | Total |
|---|---|---|---|
| Netherlands | 19 | 22 | 41 |
| Belgium | 24 | 26 | 50 |
| United States | 114 | 111 | 225 |
| Italy | 25 | 28 | 53 |
| United Kingdom | 2 | 1 | 3 |
| Indication for colonoscopy procedure(participants in ITT population) | Group A - SC Followed by TEC | Group B - TEC Followed by SC | Total |
|---|---|---|---|
| Screening | 97 | 92 | 189 |
| Surveillance | 41 | 55 | 96 |
| Diagnostic | 46 | 41 | 87 |
Plan to share: No — Aggregated, de-identified data to be published in peer-reviewed medical journal
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