Colorectal CancerNCT02066064
G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist
A study testing Standard Colonoscopy and G-EYE(TM) Colonoscopy in people with Colorectal Cancer and Adenoma, run by Smart Medical Systems Ltd. at 1 site in Germany.
Trial summary
The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenoma
- What is being tested?
- Standard Colonoscopy and G-EYE(TM) Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 50 years old
- Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
- The patient must understand and provide written consent for the procedure.
Who cannot join
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with a history of radiation therapy to abdomen or pelvis;
- Pregnant or lactating female subjects;
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- Subjects who are currently enrolled in another clinical investigation.
- Subjects with current oral or parenteral use of anticoagulants
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate - Randomized Tandem Study With Different Endoscopist
The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy.
Read the detailed description
Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.
- Conditions
- Colorectal Cancer, Adenoma
- Being tested
- Standard Colonoscopy, G-EYE(TM) Colonoscopy
- Keywords
- Colorectal Cancer, Adenoma, Standard Colonoscopy, G-EYE(TM) Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ColonoscopyProcedure or surgery
Standard Colonoscopy
G-EYE(TM) ColonoscopyProcedure or surgery
G-EYE(TM) Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy Receives: Procedure: Standard Colonoscopy; Procedure: G-EYE(TM) Colonoscopy |
| Group B | Active comparator | Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy Receives: Procedure: Standard Colonoscopy; Procedure: G-EYE(TM) Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.
Measured: estimated 14 days (following histology results)
Secondary outcomes (1)
polyp and adenoma detection, procedure times and safety
Measured: 24-72 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Kiesslich, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066064
- Sponsor's protocol ID
- G-EYE
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2014
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate - Randomized Tandem Study With Different Endoscopist
- ClinicalTrials.gov ID
- NCT02066064
- Acronym / sponsor ID
- G-EYE
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- Colorectal Cancer, Adenoma, Standard Colonoscopy, G-EYE(TM) Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
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 compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy.
Detailed description
Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Standard Colonoscopy, Procedure: G-EYE(TM) ColonoscopySubjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy |
| Group B | Active comparator | Procedure: Standard Colonoscopy, Procedure: G-EYE(TM) ColonoscopySubject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 50 years old
- Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
- The patient must understand and provide written consent for the procedure.
Key exclusion criteria (9 listed)
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with a history of radiation therapy to abdomen or pelvis;
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 |
|---|---|---|
| Standard ColonoscopyStandard Colonoscopy | Procedure or surgery | Group A, Group B |
| G-EYE(TM) ColonoscopyG-EYE(TM) Colonoscopy | Procedure or surgery | Group A, Group B |
Primary outcome
G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.
Time frame: estimated 14 days (following histology results)
1 secondary outcome
polyp and adenoma detection, procedure times and safety
Time frame: 24-72 hours post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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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.
Ralf Kiesslich, Prof. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Colonoscopy and G-EYE(TM) Colonoscopy in people with Colorectal Cancer and Adenoma, run by Smart Medical Systems Ltd. at 1 site in Germany.
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 9 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same. (time frame: estimated 14 days (following histology results)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2016.