Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenoma; Polyps
• Intervention / Treatment: Device: G-EYE™ colonoscopy; Device: Standard 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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Harlev, Denmark, 2730
    • Herlev Hospital
• Germany
  • Mainz, Germany, 55131
    • Universitätsmedizin Johannes Gutenberg University Mainz
  • Tübingen, Germany, D-72076
    • Universitätsklinikum Tübingen
  • Wiesbaden, Germany, 65199
    • Helios Dr. Horst Schmidt Kliniken (HSK)
• India
  • Hyderabad, India
    • Asian Institute of Gastroenterology
• Israel
  • Jerusalem, Israel, 91999
    • Hadassah Medical Center
  • Netanya, Israel
    • Laniado Hospital
  • Tzrifin, Israel, 70300
    • Assaf Harofeh Medical Center
• Italy
  • Milan, Italy, 20132
    • Vita Salute San Raffaele University - Scientific Institute San Raffaele
• Netherlands
  • Maastricht, Netherlands, 6202AZ
    • Maastricht University Medical Centre
  • Nijmegen, Netherlands, 6500 HB
    • Radboud UMC
• United Kingdom
  • Birmingham, United Kingdom
    • Birmingham City University
  • Dudley, United Kingdom
    • Russells Hall Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center, Harvard Medical School
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G-EYE™ colonoscopy	Device: G-EYE™ colonoscopy; G-EYE™ colonoscopy
Active Comparator: Standard Colonoscopy	Device: Standard Colonoscopy; Standard Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Smart Medical Systems Ltd.
• Investigators: Principal Investigator: Ralf Kiesslich, Prof., Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: August 4, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenoma; CRC; Polyps; Detection Yield
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: G-EYE 15505