Colorectal CancerNCT00657371
Efficacy of the Third Eye Retroscope Auxiliary Imaging System
A study testing Third Eye Retroscope Auxiliary Imaging System in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Third Eye Retroscope Auxiliary Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2008to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202
El Camino Hospital
Mountain View, California, 94040
Mayo Clinic
Scottsdale, Arizona, 85259
Washington University
St Louis, Missouri, 63130
Camino Medical Group Surgi-Center
Sunnyvale, California, 94086
About this study
Official title: A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Third Eye Retroscope Auxiliary Imaging System
- Keywords
- Colorectal Cancer, Colonoscopy, Third Eye Retroscope, Third Eye Retroscope Auxiliary Imaging System, Polypectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third Eye Retroscope Auxiliary Imaging SystemDevice
A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.
| Study group | Role | What they receive |
|---|---|---|
| Third Eye Retroscope | Experimental | Colonoscopy exam using the Third Eye Retroscope device Receives: Device: Third Eye Retroscope Auxiliary Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Total 30 minutes procedure time with TER use.
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.
Measured: Total 30 minutes procedure time with TER use.
Secondary outcomes (1)
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.
Measured: 2 year study period to collect colonoscopy exam results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Avantis Medical Systems
- Responsible party
- Sponsor
- Investigators
- Robert S. Bresalier, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657371
- Sponsor's protocol ID
- 2007-0246
- Status last verified
- Oct 2013
- First submitted
- 8 Apr 2008
- Last updated
- 9 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.
PubMed 20018280
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
- ClinicalTrials.gov ID
- NCT00657371
- Acronym / sponsor ID
- 2007-0246
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Colonoscopy, Third Eye Retroscope, Third Eye Retroscope Auxiliary Imaging System, Polypectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Avantis Medical Systems
- Study start
- Mar 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Posted 9 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Third Eye Retroscope | Experimental | Device: Third Eye Retroscope Auxiliary Imaging SystemColonoscopy exam using the Third Eye Retroscope device |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third Eye Retroscope Auxiliary Imaging SystemA thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue. | Device | Third Eye Retroscope |
Primary outcome
Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.
Time frame: 2 year study period to collect colonoscopy exam results
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20018280Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.
- The University of Texas MD Anderson Cancer Center official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S. Bresalier, MD principal investigator
M.D. Anderson Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third Eye Retroscope Auxiliary Imaging System in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER) (time frame: Total 30 minutes procedure time with TER use.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00657371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.