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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-EYE™ colonoscopy | Experimental | G-EYE™ colonoscopy |
|
| Standard Colonoscopy | Active Comparator | Standard Colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-EYE™ colonoscopy | Device | G-EYE™ colonoscopy |
| |
| Standard Colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximalty following 14 days (histology results) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 14 days (histology results) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Kiesslich, Prof. | Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center, Harvard Medical School | Boston | Massachusetts | 02115 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30273591 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Colonoscopy | Patients in this group underwent standard high definition colonoscopy |
| FG001 | G-EYE™ Colonoscopy | Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2013 | Dec 26, 2017 |
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| Device |
Standard Colonoscopy |
|
| NYU Langone Medical Center |
| New York |
| New York |
| 10016 |
| United States |
| Herlev Hospital | Harlev | 2730 | Denmark |
| Universitätsmedizin Johannes Gutenberg University Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Tübingen | Tübingen | D-72076 | Germany |
| Helios Dr. Horst Schmidt Kliniken (HSK) | Wiesbaden | 65199 | Germany |
| Asian Institute of Gastroenterology | Hyderabad | India |
| Hadassah Medical Center | Jerusalem | 91999 | Israel |
| Laniado Hospital | Netanya | Israel |
| Assaf Harofeh Medical Center | Tzrifin | 70300 | Israel |
| Vita Salute San Raffaele University - Scientific Institute San Raffaele | Milan | 20132 | Italy |
| Maastricht University Medical Centre | Maastricht | 6202AZ | Netherlands |
| Radboud UMC | Nijmegen | 6500 HB | Netherlands |
| Birmingham City University | Birmingham | United Kingdom |
| Russells Hall Hospital | Dudley | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Colonoscopy | Patients in this group underwent standard high definition colonoscopy |
| BG001 | G-EYE™ Colonoscopy | Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Approximalty following 14 days (histology results) |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Up to 14 days (histology results) | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G-EYE™ Colonoscopy | G-EYE™ colonoscopy G-EYE™ colonoscopy: G-EYE™ colonoscopy | 2 | 502 | 0 | 502 | ||
| EG001 | Standard Colonoscopy | Standard Colonoscopy Standard Colonoscopy: Standard Colonoscopy | 0 | 498 | 0 | 498 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| obstructive sigmoid tumor | Gastrointestinal disorders |
| |||
| an irregular heart rate and bradycardia prior to the initiation of the procedure | Cardiac disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Ralf Kiesslich | Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany | ralf.kiesslich@hsk-wiesbaden.de |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D011127 | Polyps |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| Male |
|