AdenomaNCT02545699
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
A study testing G-EYE™ Colonoscopy and Standard Colonoscopy in people with Adenoma and Polyps, run by Smart Medical Systems Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenoma, Polyps, Colorectal Cancer
- What is being tested?
- G-EYE™ Colonoscopy and Standard Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Jun 2017
- 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, for diagnostic evaluation 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 that have not stopped using anticoagulants as required by the guidelines of the medical center;
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- Any patient condition deemed too risky for the study by the investigator
- Previous colonic surgery (except for appendectomy)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Hospital
Haifa
Tova Rainis
Tova Rainis
About this study
Official title: Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy
The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.
Read the detailed description
This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy.
The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.
Subjects will sign an informed consent form and undergo randomization.
- Conditions
- Adenoma, Polyps, Colorectal Cancer
- Being tested
- G-EYE™ Colonoscopy, Standard Colonoscopy
- Keywords
- Adenoma, Polyp, CRC, Colonoscopy, Detection Yield
- Medical subject headings
- Adenoma, Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-EYE™ ColonoscopyDevice
G-EYE™ Colonoscopy
Standard ColonoscopyDevice
Standard Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| G-EYE™ Colonoscopy | Experimental | G-EYE™ Colonoscopy Receives: Device: G-EYE™ Colonoscopy |
| Standard Colonoscopy | Active comparator | Standard Colonoscopy Receives: Device: Standard 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: Approximately following 14 days (histology results)
Secondary outcomes (3)
Polyp and adenoma detection
The secondary outcome is a composite- each of the measured parameters will be reported as a single value for each arm.
Measured: Up to 14 days (Histology results)
Procedure times
Measured: At time of procedure
Safety (number of patients with adverse events)
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tova Rainis, Dr., Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545699
- Sponsor's protocol ID
- G-EYE 15507
- Status last verified
- Jun 2016
- First submitted
- 31 Aug 2015
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy
- ClinicalTrials.gov ID
- NCT02545699
- Acronym / sponsor ID
- G-EYE 15507
- Conditions
- Adenoma, Polyps, Colorectal Cancer
- Keywords
- Adenoma, Polyp, CRC, Colonoscopy, Detection Yield
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Sep 2015 (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 (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.
Detailed description
This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy.
The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.
Subjects will sign an informed consent form and undergo randomization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-EYE™ Colonoscopy | Experimental | Device: G-EYE™ ColonoscopyG-EYE™ Colonoscopy |
| Standard Colonoscopy | Active comparator | Device: Standard ColonoscopyStandard 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, for diagnostic evaluation or for surveillance colonoscopy (history of adenoma resection).
- The patient must understand and provide written consent for the procedure.
Key exclusion criteria (11 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 |
|---|---|---|
| G-EYE™ ColonoscopyG-EYE™ Colonoscopy | Device | G-EYE™ Colonoscopy |
| Standard ColonoscopyStandard Colonoscopy | Device | Standard Colonoscopy |
Primary outcome
G-EYE™ Colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same
Time frame: Approximately following 14 days (histology results)
3 secondary outcomes
Polyp and adenoma detection
Time frame: Up to 14 days (Histology results)
Procedure times
Time frame: At time of procedure
Safety (number of patients with adverse events)
Time frame: 48-72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 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.
Tova Rainis, Dr. principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-EYE™ Colonoscopy and Standard Colonoscopy in people with Adenoma and Polyps, run by Smart Medical Systems Ltd. at 1 site in Israel.
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 11 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: status not confirmed, as of the sponsor's last update on 7 Jun 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tova Rainis, Dr. (04-8359426, tovarainis@gmail.com), or a site near the patient. 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: Approximately following 14 days (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 7 Jun 2016.