Colorectal CancerNCT01749722
Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
A study testing NaviAid™ G-Eye procedure in people with Colorectal Cancer and Polyp, run by Smart Medical Systems Ltd. at 1 site in Israel.
Trial summary
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Polyp, Adenoma
- What is being tested?
- NaviAid™ G-Eye procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Jun 2013
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is undergoing colonoscopy for screening, for surveillance of previous colon polyp(s) or for diagnostic evaluation.
- The patient is 40-75 years old;
- The patient must understand and provide written informed consent for the procedure.
Who cannot join
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of polyposis syndrome;
- Subjects with suspected colonic stricture potentially precluding complete colonoscopy;
- Subjects with active 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 routine oral or parenteral use of anticoagulants
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
Read the detailed description
Colonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. It is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range.
The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. The NaviAid™ G-Eye may be used for performing controlled withdrawal and endoscope stabilization.
A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal.
This is a single-center, non randomized open-label study intended to evaluate the serious adverse events prevalence when using the NaviAid™ G-Eye system during colonoscopy.
- Conditions
- Colorectal Cancer, Polyp, Adenoma
- Being tested
- NaviAid™ G-Eye procedure
- Keywords
- Colorectal Cancer, Polyp, Adenoma, Detection Rate, Colonoscopy, NaviAid™ G-Eye procedure, NaviAid™ G-Eye system, G-Eye procedure, G-Eye system
- 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.
NaviAid™ G-Eye procedureDevice
NaviAid™ G-Eye procedure
| Study group | Role | What they receive |
|---|---|---|
| NaviAid™ G-Eye procedure | Experimental | NaviAid™ G-Eye procedure Receives: Device: NaviAid™ G-Eye procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
Measured: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian M Gralnek, Prof., Principal investigator, Elisha Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749722
- Sponsor's protocol ID
- G-Eye 15502
- Status last verified
- Jul 2013
- First submitted
- 11 Nov 2012
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16.
PubMed 25225962
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
- ClinicalTrials.gov ID
- NCT01749722
- Acronym / sponsor ID
- G-Eye 15502
- Conditions
- Colorectal Cancer, Polyp, Adenoma
- Keywords
- Colorectal Cancer, Polyp, Adenoma, Detection Rate, Colonoscopy, NaviAid™ G-Eye procedure, NaviAid™ G-Eye system, G-Eye procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Dec 2012 (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.
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
Detailed description
Colonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. It is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range.
The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. The NaviAid™ G-Eye may be used for performing controlled withdrawal and endoscope stabilization.
A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal.
This is a single-center, non randomized open-label study intended to evaluate the serious adverse events prevalence when using the NaviAid™ G-Eye system during colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NaviAid™ G-Eye procedure | Experimental | Device: NaviAid™ G-Eye procedureNaviAid™ G-Eye procedure |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is undergoing colonoscopy for screening, for surveillance of previous colon polyp(s) or for diagnostic evaluation.
- The patient is 40-75 years old;
- The patient must understand and provide written informed consent for the procedure.
Key exclusion criteria (10 listed)
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of polyposis syndrome;
- Subjects with suspected colonic stricture potentially precluding complete colonoscopy;
- Subjects with active 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 |
|---|---|---|
| NaviAid™ G-Eye procedureNaviAid™ G-Eye procedure | Device | NaviAid™ G-Eye procedure |
Primary outcome
Number of adverse events
Time frame: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
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 30 Jul 2013.
- Derived from this study: PubMed 25225962Gralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16.
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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.
Ian M Gralnek, Prof. principal investigator
Elisha Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviAid™ G-Eye procedure in people with Colorectal Cancer and Polyp, 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 10 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 30 Jul 2013. 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?
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?
Number of adverse events (time frame: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure). 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 NCT01749722, 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 30 Jul 2013.