search
Back to results

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

Primary Purpose

Adenoma, Polyps, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
G-EYE™ colonoscopy
Standard Colonoscopy
Sponsored by
Smart Medical Systems Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma focused on measuring Adenoma, Polyps, CRC, Colonoscopy, Detection Yield

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Beth Israel Deaconess Medical Center, Harvard Medical School
  • NYU Langone Medical Center
  • Herlev Hospital
  • Universitätsmedizin Johannes Gutenberg University Mainz
  • Universitätsklinikum Tübingen
  • Helios Dr. Horst Schmidt Kliniken (HSK)
  • Asian Institute of Gastroenterology
  • Hadassah Medical Center
  • Laniado Hospital
  • Assaf Harofeh Medical Center
  • Vita Salute San Raffaele University - Scientific Institute San Raffaele
  • Maastricht University Medical Centre
  • Radboud UMC
  • Birmingham City University
  • Russells Hall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G-EYE™ colonoscopy

Standard Colonoscopy

Arm Description

G-EYE™ colonoscopy

Standard Colonoscopy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2013
Last Updated
December 26, 2017
Sponsor
Smart Medical Systems Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01917513
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smart Medical Systems Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Polyps, Colorectal Cancer
Keywords
Adenoma, Polyps, CRC, Colonoscopy, Detection Yield

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-EYE™ colonoscopy
Arm Type
Experimental
Arm Description
G-EYE™ colonoscopy
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Standard Colonoscopy
Intervention Type
Device
Intervention Name(s)
G-EYE™ colonoscopy
Intervention Description
G-EYE™ colonoscopy
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
Standard Colonoscopy
Primary Outcome Measure Information:
Title
Detection Rate of Adenomas and Serrated Lesions
Description
The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
Time Frame
Approximalty following 14 days (histology results)
Secondary Outcome Measure Information:
Title
Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.
Description
The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm
Time Frame
Up to 14 days (histology results)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Kiesslich, Prof.
Organizational Affiliation
Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Herlev Hospital
City
Harlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Universitätsmedizin Johannes Gutenberg University Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Helios Dr. Horst Schmidt Kliniken (HSK)
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
Country
India
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91999
Country
Israel
Facility Name
Laniado Hospital
City
Netanya
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Tzrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Vita Salute San Raffaele University - Scientific Institute San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6202AZ
Country
Netherlands
Facility Name
Radboud UMC
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Birmingham City University
City
Birmingham
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30273591
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs