Comparison of precancerous lesions detection between standard colonoscopy and novel balloon colonoscopy
| ISRCTN | ISRCTN70400953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70400953 |
| ClinicalTrials.gov number | NCT01917513 |
| Secondary identifying numbers | G-EYE15505 |
- Submission date
- 17/12/2014
- Registration date
- 14/01/2015
- Last edited
- 10/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Ludwig-Erhard- Straße 100
Wiesbaden
65199
Germany
Public
5 HaNofar St.
Ra'anana
4366404
Israel
Study information
| Study design | Randomized interventional multicentre open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prospective randomized trial to compare the clinical efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy with Standard HD Colonoscopy |
| Study objectives | G-EYE™ HD colonoscopy detects substantially more adenomas and serrated lesions compared with Standard HD colonoscopy. |
| Ethics approval(s) | Landesarzlekammer Hessen Ethics Committee, 13/01/2014, ref: FF133/2013 |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | The trial contains two arms: 1. Investigational arm: G-EYE™ colonoscopy 2. Control arm: standard colonoscopy |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 26/05/2014 |
| Completion date | 23/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 26/05/2014 |
| Date of final enrolment | 21/09/2016 |
Locations
Countries of recruitment
- Denmark
- England
- Germany
- India
- Israel
- Italy
- Netherlands
- United Kingdom
- United States of America
Study participating centres
Jerusalem
91120
Israel
Wiesbaden
65199
Germany
DY1 2HQ
United Kingdom
Herlev
2730
Denmark
Netanya
42150
Israel
Tübingen
D-72076
Germany
Milano
20132
Italy
Maastricht
6202 AZ
Netherlands
Tzrifin
70300
Israel
Hyderabad
500 082
India
New York
10016
United States of America
Mainz
55131
Germany
330 Brookline Ave
Boston
02215
United States of America
Nijmegen
6525
Netherlands
B4 7BD
United Kingdom
Sponsor information
Industry
5 HaNofar St.
Ra'anana
4366404
Israel
| Website | http://www.smartmedsys.com/ |
|---|---|
"ROR" |
https://ror.org/01w50vm31 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V1 | 09/07/2013 | 08/01/2018 | No | No |
| Results article | results | 01/03/2019 | 10/04/2019 | Yes | No |
Additional files
- ISRCTN70400953_PROTOCOL_V1_09Jul13.pdf
- Uploaded 08/01/2018
Editorial Notes
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.
