Comparison of precancerous lesions detection between standard colonoscopy and novel balloon colonoscopy

Plain English Summary

Background and study aims
A colonoscopy is a procedure used to examine the large bowel, the colon or the rectum. Colorectal cancer can be diagnosed using this type of procedure. The procedure involves the use of a device called a colonoscope. This study compares two devices and the aim is to assess which device will detect the highest number of precancerous lesions.

Who can participate?
Adult healthy volunteers over 50 referred for colonoscopy.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 undergo a colonoscopy using a standard colonosope. Those in group 2 undergo a colonoscopy using a G-EYE HD colonoscope.

What are the possible benefits and risks of participating?
Based on previous studies, use of the G-EYE colonoscope leads to improved detection of adenomas and serrated lesions. The G-EYE colonoscope is CE marked and used like any other colonoscope. Any complications that may result from the procedure are the same as those associated with a standard colonoscopy.

Where is the study run from?
A number of hospitals in Europe, Israel, India and the USA

When is the study starting and how long is it expected to run for?
May 2014 to January 2018

Who is funding the study?
Smart Medical Systems Ltd (Israel)

Who is the main contact?
Ms Avda Yoelzon

Trial website

Type

Scientific

Primary contact

Mr Ralf Kiesslich

ORCID ID

Contact details

Ludwig-Erhard- Straße 100
Wiesbaden
65199
Germany

Type

Public

Additional contact

Mrs Adva Yoselzon

ORCID ID

Contact details

5 HaNofar St.
Ra'anana
4366404
Israel

EudraCT number

ClinicalTrials.gov number

NCT01917513

Protocol/serial number

G-EYE15505

Scientific title

Prospective randomized trial to compare the clinical efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy with Standard HD Colonoscopy

Acronym

Study hypothesis

G-EYE™ HD colonoscopy detects substantially more adenomas and serrated lesions compared with Standard HD colonoscopy.

Ethics approval

Landesarzlekammer Hessen Ethics Committee, 13/01/2014, ref: FF133/2013

Study design

Randomized interventional multicentre open-label trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Colorectal cancer

Intervention

The trial contains two arms:
1. Investigational arm: G-EYE™ colonoscopy
2. Control arm: standard colonoscopy

Intervention type

Device

Phase

Drug names

Primary outcome measure

Adenomas and serrated lesions detection rate: the percentage of subjects with at least one adenoma or serrated lesion found in each of the study groups. Timepoint: up to 14 days following procedure (histology results)

Secondary outcome measures

1. Polyp and adenoma detection: number of polyps and adenomas detected. Timepoint: up to 14 days following procedure (histology results)
2. Procedural times: minutes. Timepoint: During the procedure
3. Safety: number and severity of adverse events. Timepoint: During the procedure, post procedure, during follow-up calls or during unscheduled visits of the subjects

Overall trial start date

26/05/2014

Overall trial end date

23/10/2017

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Patients over 50
2. Referred to colonoscopy for screening, following positive Fecal Occult Blood Test (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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant 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)

Recruitment start date

26/05/2014

Recruitment end date

21/09/2016

Countries of recruitment

Denmark, Germany, India, Israel, Italy, Netherlands, United Kingdom, United States of America

Trial participating centre

Hadassah Medical Center
Kiryat Hadassah, POB 12000
Jerusalem
91120
Israel

Trial participating centre

HSK, Dr. Horst Schmidt Kliniken GmbH
Ludwig-Erhard- Straße 100
Wiesbaden
65199
Germany

Trial participating centre

Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Trial participating centre

Copenhagen University Hospital Herlev
Herlev Ringvej 75
Herlev
2730
Denmark

Trial participating centre

Laniado Hospital
Kiryat Sanz
Netanya
42150
Israel

Trial participating centre

Universitätsklinikum Tübingen
Otfried-Müller-Str. 10
Tübingen
D-72076
Germany

Trial participating centre

San Raffaele Hospital - Milan
via Olgettina 60
Milano
20132
Italy

Trial participating centre

Maastricht University Medical Centre
Postbox 5800
Maastricht
6202 AZ
Netherlands

Trial participating centre

Assaf Harofe
Tzrifin
Tzrifin
70300
Israel

Trial participating centre

Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad
500 082
India

Trial participating centre

NYU Langone Medical Center
333 E 38th St
New York
10016
United States of America

Trial participating centre

Universitätsmedizin Johannes Gutenberg University Mainz
Langenbeckstraße 1
Mainz
55131
Germany

Trial participating centre

Beth Israel Deaconess Medical Center
Harvard Medical School 330 Brookline Ave
Boston
02215
United States of America

Trial participating centre

UMC Radboud
Geert Grooteplein Zuid 10
Nijmegen
6525
Netherlands

Trial participating centre

Birmingham City University
Birmingham
B4 7BD
United Kingdom

Organisation

Smart Medical Systems Ltd

Sponsor details

5 HaNofar St.
Ra'anana
4366404
Israel

Sponsor type

Industry

Website

http://www.smartmedsys.com/

Funder type

Industry

Funder name

Smart Medical Systems Ltd (Israel)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Plans to submit all of the results to a medical journal at December 2017.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Adva Yoselzon.

Intention to publish date

31/01/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30273591 (added 10/04/2019)

Publication citations

• ISRCTN70400953_PROTOCOL_V1_09Jul13.pdf Uploaded 08/01/2018

10/04/2019: Publication reference added. 08/01/2018: Uploaded protocol V1 09 July 2013 (not peer reviewed) 11/12/2017: The following changes were made to the trial record: 1. The overall trial end date was updated from 31/01/2017 to 23/10/2017 2. Birmingham City University was added as a trial participating centre 3. The publication and dissemination plan was added 4. The intention to publish date has updated from 30/04/2017 to 31/01/2018 17/11/2016: the following changes were made to the trial record: 1. The recruitment end date was changed from 31/10/2014 to 21/09/2016. 2. The overall trial start date was changed from 09/07/2013 to 26/05/2014. 3. The overall trial end date was changed from 31/12/2015 to 31/01/2017. 4. France, Spain and Turkey were removed from the countries of recruitment. 5. India and USA were added to the countries of recruitment.