Colorectal NeoplasmsNCT00969124
Impact of Experience on Results With the Third Eye Retroscope
A study testing Third Eye Retroscope in people with Colorectal Neoplasms, run by Avantis Medical Systems at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Third Eye Retroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2009to Oct 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Florida Hospital
Celebration, Florida, 34747
University of Chicago
Chicago, Illinois, 60637
Parkland Hospital
Dallas, Texas, 75235
Baylor University Medical Center
Dallas, Texas, 75246
NorthShore University HealthSystem
Evanston, Illinois, 60201
S.W. Fort Worth Endoscopy Center
Fort Worth, Texas, 76132
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
North Hills Hospital
North Richland Hills, Texas, 76180
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy
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.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Third Eye Retroscope
- Keywords
- colonoscopy, polyps, adenomas, miss rates
- Medical subject headings
- Colorectal Neoplasms, Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third Eye RetroscopeDevice
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Third Eye Retroscope | Experimental | 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. Receives: Device: Third Eye Retroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Rates for Adenomas
Adenomas detected with the colonoscope alone vs. with the Retroscope
Measured: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Detection Rates for All Polyps
All polyps detected with the colonoscope alone vs. with the Retroscope
Measured: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Secondary outcomes (1)
Time Spent During Withdrawal Phase and Total Procedure
Time in minutes for withdrawal phase of procedure and for total procedure
Measured: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionOct 2009
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 NeoplasmsStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avantis Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel C DeMarco, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969124
- Sponsor's protocol ID
- Avantis TER 08-07
- Status last verified
- Jun 2017
- First submitted
- 27 Aug 2009
- Last updated
- 26 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
PubMed 20189513
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy
- ClinicalTrials.gov ID
- NCT00969124
- Acronym / sponsor ID
- Avantis TER 08-07
- Conditions
- Colorectal Neoplasms
- Keywords
- colonoscopy, polyps, adenomas, miss rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Avantis Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Posted 26 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- 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 RetroscopeAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 RetroscopeThird Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy | Device | Third Eye Retroscope |
Primary outcome
Detection Rates for Adenomas
Time frame: 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
Time frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
All polyps detected with the colonoscope alone vs. with the Retroscope
1 secondary outcome
Time Spent During Withdrawal Phase and Total Procedure
Time frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20189513DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
- Individual participant dataSharing planned: No
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Daniel C DeMarco, MD principal investigator
Baylor Health Care System
9 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 in people with Colorectal Neoplasms, run by Avantis Medical Systems at 9 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 2 inclusion and 7 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 26 Jul 2017). 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?
Detection Rates for Adenomas (time frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes)). 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 NCT00969124, 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 26 Jul 2017.