Clinical trial NCT01917513: Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Official title: Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Polyps
Colorectal Cancer
Keywords: Adenoma
Polyps
CRC
Colonoscopy
Detection Yield
Lead sponsor: Smart Medical Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Patients over 50 years old
2. Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
3. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

1. Subjects with inflammatory bowel disease;
2. Subjects with a personal history of polyposis syndrome;
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
4. Subjects with diverticulitis or toxic megacolon;
5. Subjects with a history of radiation therapy to abdomen or pelvis;
6. Pregnant or lactating female subjects;
7. Subjects who are currently enrolled in another clinical investigation.
8. Subjects with current oral or parenteral use of anticoagulants
9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
10. Any patient condition deemed too risky for the study by the investigator
11. Previous colonic surgery (except for appendectomy)

Primary outcomes:
measure: Detection Rate of Adenomas and Serrated Lesions
timeFrame: Approximalty following 14 days (histology results)
Secondary outcomes:
measure: Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.
timeFrame: Up to 14 days (histology results)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Harvard Medical School
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Harlev
country: Denmark
facility: Herlev Hospital
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg University Mainz
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken (HSK)
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Netanya
country: Israel
facility: Laniado Hospital
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Milan
country: Italy
facility: Vita Salute San Raffaele University - Scientific Institute San Raffaele
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Birmingham
country: United Kingdom
facility: Birmingham City University
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
Study officials:
affiliation: Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany
name: Ralf Kiesslich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.