Colorectal Neoplasms
Conditions
Keywords
colonoscopy, polyps, adenomas, miss rates
Brief summary
The Third Eye Retroscope is a device that can be used with a colonoscope to improve the ability of a physician to see areas of the colon that may be hidden from the view of the colonoscope. Previous studies have shown that physicians are able to detect additional polyps when they use the device along with the colonoscope. The purpose of this study is to determine whether physicians can detect greater numbers of additional polyps as they gain in experience with the device.
Detailed description
Purpose: This study is intended to determine characteristics of the learning curve for use of the Third Eye Retroscope during colonoscopy, both in terms of efficacy for detection of abnormalities in the colon and time-efficiency for endoscopists Device Description: The Third Eye Retroscope is an auxiliary imaging device that is designed to allow visualization of hidden areas during colonoscopy by providing an additional, retrograde view that complements the forward view of the colonoscope. After a standard colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As it emerges from the distal tip of the colonoscope, the Third Eye Retroscope automatically bends 180 degrees to form a J shape. Its sensor then provides a continuous retrograde view of the colon throughout the process of withdrawal of the colonoscope. The retrograde view assists the endoscopist in visualizing the proximal aspect of haustral folds and rectal valves, as well as the areas behind flexures and the ileocecal valve. With this additional point-of-view, the endoscopist may be able to detect lesions that can be missed by the forward-viewing colonoscope. Study Design: Patients who are scheduled for colonoscopy will be recruited to the study and examined with the Third Eye Retroscope in conjunction with a standard colonoscope. For each polyp that is found, the endoscopist will indicate whether it could be seen with the colonoscope, or if it could be found with the colonoscope only because it was first detected with the Third Eye. Each investigator will perform colonoscopies on 20 patients, who will be segmented into four quartiles according to the order of their procedures. Mean results for the quartiles will be compared in order to evaluate the learning curve for Third Eye colonoscopy.
Interventions
DEVICEThird Eye Retroscope
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy
Sponsors
Avantis Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; 2. The patient must understand and provide written consent for the procedure.
Exclusion criteria
1. Patients with a history of colonic resection; 2. Patients with inflammatory bowel disease; 3. Patients with a personal history of polyposis syndrome; 4. Patients with suspected chronic stricture potentially precluding complete colonoscopy; 5. Patients with diverticulitis or toxic megacolon; 6. Patients with a history of radiation therapy to abdomen or pelvis. 7. 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 | During the colonoscopy procedure (up to 1 hour, average 25 minutes) | Adenomas detected with the colonoscope alone vs. with the Retroscope |
| Detection Rates for All Polyps | During the colonoscopy procedure (up to 1 hour, average 25 minutes) | All polyps detected with the colonoscope alone vs. with the Retroscope |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent During Withdrawal Phase and Total Procedure | During the colonoscopy procedure (up to 1 hour, average 25 minutes) | Time in minutes for withdrawal phase of procedure and for total procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Third Eye Retroscope All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure. | 298 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inability to reach cecum | 9 |
| Overall Study | Inadequate bowel preparation | 15 |
| Overall Study | Previously unrecognized disease | 3 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Technical error | 1 |
Baseline characteristics
| Characteristic | Third Eye Retroscope |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 11.3 |
| Indication for colonoscopy procedure (screening, surveillance or diagnostic) Diagnostic | 72 participants |
| Indication for colonoscopy procedure (screening, surveillance or diagnostic) Screening | 164 participants |
| Indication for colonoscopy procedure (screening, surveillance or diagnostic) Surveillance | 62 participants |
| Region of Enrollment United States | 298 participants |
| Sex: Female, Male Female | 154 Participants |
| Sex: Female, Male Male | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 298 |
| serious Total, serious adverse events | 0 / 298 |
Outcome results
Primary
Detection Rates for Adenomas
Adenomas detected with the colonoscope alone vs. with the Retroscope
Time frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Third Eye Retroscope | Detection Rates for Adenomas | Adenomas detected with colonoscope alone | 100 Adenomas |
| Third Eye Retroscope | Detection Rates for Adenomas | Additional adenomas detected with Retroscope | 16 Adenomas |
Primary
Detection Rates for All Polyps
All polyps detected with the colonoscope alone vs. with the Retroscope
Time frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Third Eye Retroscope | Detection Rates for All Polyps | All polyps detected with colonoscope alone | 182 All polyps |
| Third Eye Retroscope | Detection Rates for All Polyps | Additional all polyps detected with Retroscope | 27 All polyps |
Secondary
Time Spent During Withdrawal Phase and Total Procedure
Time in minutes for withdrawal phase of procedure and for total procedure
Time frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Third Eye Retroscope | Time Spent During Withdrawal Phase and Total Procedure | Average withdrawal time | 9.9 minutes | Standard Deviation 4.1 |
| Third Eye Retroscope | Time Spent During Withdrawal Phase and Total Procedure | Average total procedure time | 24.7 minutes | Standard Deviation 9.7 |