AdenomaNCT01917513
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
A study testing G-EYE™ colonoscopy and Standard Colonoscopy in people with Adenoma and Polyps, run by Smart Medical Systems Ltd. at 15 sites in 8 countries.
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
- 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
- 1,000 participants
- Where
- 15 sitesin 8 countries
- Study dates
- May 2014to Sep 2016
- 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 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;
Show all 11Show fewer
- 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)
- Any patient condition deemed too risky for the study by the investigator
- Previous colonic surgery (except for appendectomy)
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
Germany3 sites
Universitätsmedizin Johannes Gutenberg University Mainz
Mainz, 55131
Universitätsklinikum Tübingen
Tübingen, D-72076
Helios Dr. Horst Schmidt Kliniken (HSK)
Wiesbaden, 65199
Israel3 sites
Hadassah Medical Center
Jerusalem, 91999
Laniado Hospital
Netanya
Assaf Harofeh Medical Center
Tzrifin, 70300
United States2 sites
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, 02115
NYU Langone Medical Center
New York, New York, 10016
Netherlands2 sites
Maastricht University Medical Centre
Maastricht, 6202AZ
Radboud UMC
Nijmegen, 6500 HB
United Kingdom2 sites
Birmingham City University
Birmingham
Russells Hall Hospital
Dudley
Italy1 site
Vita Salute San Raffaele University - Scientific Institute San Raffaele
Milan, 20132
About this study
Official title: Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
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
This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ high definition colonoscopy vs. the detection rate obtained by performing high definition standard colonoscopy.
The study will enroll 1000 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.
Subjects will sign informed consent form and undergo randomization. The study includes a run-in preliminary phase of 270 patients to allow physicians to get familiar with the G-EYE™ endoscope.
- Conditions
- Adenoma, Polyps, Colorectal Cancer
- Being tested
- G-EYE™ colonoscopy, Standard Colonoscopy
- Keywords
- Adenoma, Polyps, 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.
Detection Rate of Adenomas and Serrated Lesions
The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
Measured: Approximalty following 14 days (histology results)
Secondary outcomes (1)
Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2016
- Study completionSep 2016
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 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
- 1,000 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, Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917513
- Sponsor's protocol ID
- G-EYE 15505
- Status last verified
- Dec 2017
- First submitted
- 30 Jul 2013
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shirin H, Shpak B, Epshtein J, Karstensen JG, Hoffman A, de Ridder R, Testoni PA, Ishaq S, Reddy DN, Gross SA, Neumann H, Goetz M, Abramowich D, Moshkowitz M, Mizrahi M, Vilmann P, Rey JW, Sanduleanu-Dascalescu S, Viale E, Chaudhari H, Pochapin MB, Yair M, Shnell M, Yaari S, Hendel JW, Teubner D, Bogie RMM, Notaristefano C, Simantov R, Gluck N, Israeli E, Stigaard T, Matalon S, Vilkin A, Benson A, Sloth S, Maliar A, Waizbard A, Jacob H, Thielsen P, Shachar E, Rochberger S, Hershcovici T, Plougmann JI, Braverman M, Tsvang E, Abedi AA, Brachman Y, Siersema PD, Kiesslich R. G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos). Gastrointest Endosc. 2019 Mar;89(3):545-553. doi: 10.1016/j.gie.2018.09.028. Epub 2018 Sep 28.
PubMed 30273591
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
- ClinicalTrials.gov ID
- NCT01917513
- Acronym / sponsor ID
- G-EYE 15505
- Conditions
- Adenoma, Polyps, Colorectal Cancer
- Keywords
- Adenoma, Polyps, CRC, Colonoscopy, Detection Yield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 23 Jan 2018
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
This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ high definition colonoscopy vs. the detection rate obtained by performing high definition standard colonoscopy.
The study will enroll 1000 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.
Subjects will sign informed consent form and undergo randomization. The study includes a run-in preliminary phase of 270 patients to allow physicians to get familiar with the G-EYE™ endoscope.
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 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
Detection Rate of Adenomas and Serrated Lesions
Time frame: Approximalty following 14 days (histology results)
The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
1 secondary outcome
Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.
Time frame: Up to 14 days (histology results)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30273591Shirin H, Shpak B, Epshtein J, Karstensen JG, Hoffman A, de Ridder R, Testoni PA, Ishaq S, Reddy DN, Gross SA, Neumann H, Goetz M, Abramowich D, Moshkowitz M, Mizrahi M, Vilmann P, Rey JW, Sanduleanu-Dascalescu S, Viale E, Chaudhari H, Pochapin MB, Yair M, Shnell M, Yaari S, Hendel JW, Teubner D, Bogie RMM, Notaristefano C, Simantov R, Gluck N, Israeli E, Stigaard T, Matalon S, Vilkin A, Benson A, Sloth S, Maliar A, Waizbard A, Jacob H, Thielsen P, Shachar E, Rochberger S, Hershcovici T, Plougmann JI, Braverman M, Tsvang E, Abedi AA, Brachman Y, Siersema PD, Kiesslich R. G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos). Gastrointest Endosc. 2019 Mar;89(3):545-553. doi: 10.1016/j.gie.2018.09.028. Epub 2018 Sep 28.
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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
Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany
15 sites in 8 countries: 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 15 sites in 8 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 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: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Israel, United States, Netherlands, United Kingdom and 3 more countries. 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 23 Jan 2018). 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 Rate of Adenomas and Serrated Lesions (time frame: Approximalty 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?
On the ClinicalTrials.gov record for NCT01917513, 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 23 Jan 2018.