Colorectal NeoplasmsTERRACENCT01044732
Third Eye Retroscope Randomized Clinical Evaluation
A study testing Third Eye Retroscope in people with Colorectal Neoplasms, run by Avantis Medical Systems at 9 sites in 5 countries.
Trial summary
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. 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
- 448 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Mar 2009to Feb 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 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 5 countries.
9 sites in 5 countries
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Baylor University Medical Center
Dallas, Texas, 75246
Kansas City Veterans Administration Medical Center
Kansas City, Missouri, 64128
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Bayside Endoscopy Center
Providence, Rhode Island, 02905
About this study
Official title: Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)
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.
Read the detailed description
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Third Eye Retroscope
- Keywords
- Colorectal, Neoplasms, Adenomas, Polyps, Miss rates, Detection rates, Colonoscope, Third Eye Retroscope
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Adenoma, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third Eye RetroscopeDevice
Device used with colonoscope to provide second, retrograde view of the colon
| Study group | Role | What they receive |
|---|---|---|
| Group A - COLO, then TER | Experimental | Complete examination with standard colonoscope ("COLO") followed by complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope Receives: Device: Third Eye Retroscope |
| Group B - TER, then COLO | Active comparator | Complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope ("COLO") alone 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 and for Total Polyps
Numbers of polyps and adenomas detected in first and second procedures for each group
Measured: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
Secondary outcomes (1)
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
Measured: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 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 (2)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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avantis Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter D. Siersema, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044732
- Sponsor's protocol ID
- Avantis TER-08-06
- Acronym
- TERRACE
- Status last verified
- Jun 2017
- First submitted
- 6 Jan 2010
- Last updated
- 25 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregated, de-identified data to be published in peer-reviewed medical journal
Publications
Leufkens AM, DeMarco DC, Rastogi A, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, Siersema PD; Third Eye Retroscope Randomized Clinical Evaluation [TERRACE] Study Group. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc. 2011 Mar;73(3):480-9. doi: 10.1016/j.gie.2010.09.004. Epub 2010 Nov 10.
PubMed 21067735Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.
PubMed 22807609
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)
- ClinicalTrials.gov ID
- NCT01044732
- Acronym / sponsor ID
- TERRACE / Avantis TER-08-06
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal, Neoplasms, Adenomas, Polyps, Miss rates, Detection rates, Colonoscope, Third Eye Retroscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Avantis Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 1 Oct 2015
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 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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - COLO, then TER | Experimental | Device: Third Eye RetroscopeComplete examination with standard colonoscope ("COLO") followed by complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope |
| Group B - TER, then COLO | Active comparator | Device: Third Eye RetroscopeComplete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope ("COLO") alone |
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 RetroscopeDevice used with colonoscope to provide second, retrograde view of the colon | Device | Group A - COLO, then TER, Group B - TER, then COLO |
Primary outcome
Detection Rates for Adenomas and for Total Polyps
Time frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
Numbers of polyps and adenomas detected in first and second procedures for each group
1 secondary outcome
Times for Withdrawal Phase and for Complete Procedure
Time frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21067735Leufkens AM, DeMarco DC, Rastogi A, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, Siersema PD; Third Eye Retroscope Randomized Clinical Evaluation [TERRACE] Study Group. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc. 2011 Mar;73(3):480-9. doi: 10.1016/j.gie.2010.09.004. Epub 2010 Nov 10.
- Results publication: PubMed 22807609Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.
- Individual participant dataSharing planned: No. Aggregated, de-identified data to be published in peer-reviewed medical journal
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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.
Peter D. Siersema, MD, PhD principal investigator
UMC Utrecht
9 sites in 5 countries: 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 5 countries.
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 25 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, Belgium, Italy, Netherlands, United Kingdom. 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 1 Oct 2015). 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 and for Total Polyps (time frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.). 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 NCT01044732, which also lists 2 linked publications.
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 25 Jul 2017.