Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Colonoscopy, Third Eye Retroscope, Third Eye Retroscope Auxiliary Imaging System, Polypectomy
Brief summary
The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope auxiliary imaging system. The primary objective of this study is to assess the degree to which incorporating the Third Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the detection of additional polyps. Specifically, the primary goals are to estimate (1) the proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope, and (2) the proportion of patients found under this protocol to have polyps who would have incorrectly been classified as polyp-free had the Third Eye Retroscope not been used.
Detailed description
THE STUDY DEVICE: The Third Eye Retroscope is a thin, flexible probe that can be inserted in a standard colonoscope in order to display very detailed images of the colon tissue. It contains a miniature video camera that allows the doctor to see an additional point of view that looks backward while the regular colonoscope and study device are moved together through the length of the colon. For you to be eligible to take part in this study, your doctor will check to be sure you have no medical conditions that would increase your risk of having any complications as a result of having the study device used during your colonoscopy. STUDY PROCEDURES: If you are found to be eligible to take part in this study, your doctor will perform your colonoscopy exam in the usual manner except that the Third Eye Retroscope device will be used during the exam as well. Your doctor will insert the colonoscope into your rectum in the usual manner and will then insert the study device down a channel inside the colonoscope. You will sign a separate consent form for the colonoscopy, which will describe the procedure and its risks in more detail. During the exam, you will be awake. If you have chosen to use medications for conscious sedation, you will be drowsy. FOLLOW-UP PHONE CALL: About 48 hours (2 days) after the study procedure, you will be called by the research staff to see how you are doing. After this follow-up call, your participation in this study will be over. This is an investigational study. The Third Eye Retroscope device is commercially available, but it is not FDA approved for this study's purpose. At this time, for this purpose, it is being used in research only. Up to 700 patients will take part in this study. Up to 100 will be enrolled at M. D. Anderson.
Interventions
DEVICEThird Eye Retroscope Auxiliary Imaging System
A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.
Sponsors
Avantis Medical Systems
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patient is undergoing colonoscopy for screening purposes or for surveillance in follow-up for previous polypectomy. * The patient is at satisfactory risk for abdominal surgery. * The patient must understand and provide written consent for the procedure.
Exclusion criteria
* Patients who are \<50 years or \>80 years of age * Patients who are pregnant. * Patients with history of colonic resection. * Patients requiring ongoing anticoagulation therapy. * Patients with a history of severe cardiovascular, pulmonary, liver or renal disease. * Patients with hypersensitivity to opioid analgesics. * Patients with an active systemic infection. * Patients with suspected chronic stricture potentially precluding complete colonoscopy. * Patients with major psychiatric disease (dementia, schizophrenia or depression). * Patients with diverticulitis or toxic megacolon. * Patients with 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 |
|---|---|---|
| Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER) | Total 30 minutes procedure time with TER use. | After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results. |
| Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) | Total 30 minutes procedure time with TER use. | After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used. | 2 year study period to collect colonoscopy exam results | Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: March 05, 2008 to May 16, 2010 with recruitment completed in medical settings including university medical centers, ambulatory surgery centers, a community medical center and a physician's office.
Participants by arm
| Arm | Count |
|---|---|
| Third Eye Retroscope Colonoscopy exam using the Third Eye Retroscope device | 288 |
| Total | 288 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device- related reasons | 13 |
| Overall Study | Poor bowel preparation | 15 |
| Overall Study | Pre-existing medical condition | 4 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Unable to intubate the cecum | 5 |
Baseline characteristics
| Characteristic | Third Eye Retroscope |
|---|---|
| Age Continuous | 63 years FULL_RANGE 6.5 |
| Region of Enrollment United States | 288 participants |
| Sex: Female, Male Female | 156 Participants |
| Sex: Female, Male Male | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 288 |
| serious Total, serious adverse events | 0 / 288 |
Outcome results
Primary
Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)
After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
Time frame: Total 30 minutes procedure time with TER use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Third Eye Retroscope | Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER) | 13.2 percent of polyps |
Primary
Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)
After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
Time frame: Total 30 minutes procedure time with TER use.
Population: Those polyps reported for Third Eye Retroscope were additional, located behind folds and then found with the colonscope only because they were first detected with the Third Eye Retroscope.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Third Eye Retroscope | Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) | Standard Colonoscope (Total) | 257 polyps |
| Third Eye Retroscope | Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) | Third Eye Retroscope | 34 polyps |
Secondary
Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.
Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.
Time frame: 2 year study period to collect colonoscopy exam results