Colorectal AdenomaG-EYE-ADRNCT03961893
Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
A study testing G-EYE first and standard colonoscope and standard colonoscope first and G-EYE in people with Colorectal Adenoma, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- G-EYE first and standard colonoscope and standard colonoscope first and G-EYE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2020to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
- FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
- Consent of participation signed,
- Affiliation to a social security scheme, or beneficiary of such a scheme.
Who cannot join
- Non-optimal preparation (boston score <7 or segment <2),
- Adenomatous polyposis, familial or assimilated (juvenile, etc.),
- Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
- Patient in emergency or deprived of liberty or placed under the authority of a tutor,
- Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.
- Conditions
- Colorectal Adenoma
- Being tested
- G-EYE first and standard colonoscope, standard colonoscope first and G-EYE
- Keywords
- colonoscopy, g-eye, adenomas
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-EYE first and standard colonoscopeDevice
Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy
standard colonoscope first and G-EYEDevice
Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard colonoscopy then colonoscopy with G-EYE | Experimental | Arm A: Standard colonoscopy then colonoscopy with G-EYE Receives: Device: standard colonoscope first and G-EYE |
| Arm B: G-EYE colonoscopy then standard colonoscopy | Experimental | Arm B: G-EYE colonoscopy then standard colonoscopy Receives: Device: G-EYE first and standard colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections
Measured: Colonoscopy time
Secondary outcomes (6)
Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections
Measured: Colonoscopy time
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female
Measured: Colonoscopy time
Rate of complications
Global and for each arm
Measured: Colonoscopy time and 1 month after
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup
Measured: Colonoscopy time
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup
Measured: Colonoscopy time
G-EYE assistance for endoscope stabilization
Yes or no
Measured: Colonoscopy time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start21 Jan 2020
- Primary completion19 May 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-phase, two-stage, randomized phase II study
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe RATONE, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961893
- Sponsor's protocol ID
- G-EYE-ADR-IPC 2016-023
- Other IDs
- 2018-A03292-53
- Acronym
- G-EYE-ADR
- Status last verified
- May 2023
- First submitted
- 21 May 2019
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT03961893
- Acronym / sponsor ID
- G-EYE-ADR / G-EYE-ADR-IPC 2016-023
- Conditions
- Colorectal Adenoma
- Keywords
- colonoscopy, g-eye, adenomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-phase, two-stage, randomized phase II study
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard colonoscopy then colonoscopy with G-EYE | Experimental | Device: standard colonoscope first and G-EYEArm A: Standard colonoscopy then colonoscopy with G-EYE |
| Arm B: G-EYE colonoscopy then standard colonoscopy | Experimental | Device: G-EYE first and standard colonoscopeArm B: G-EYE colonoscopy then standard colonoscopy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
- FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
- Consent of participation signed,
- Affiliation to a social security scheme, or beneficiary of such a scheme.
Key exclusion criteria (5 listed)
- Non-optimal preparation (boston score <7 or segment <2),
- Adenomatous polyposis, familial or assimilated (juvenile, etc.),
- Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
- Patient in emergency or deprived of liberty or placed under the authority of a tutor,
- Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-EYE first and standard colonoscopePatients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy | Device | Arm B: G-EYE colonoscopy then standard colonoscopy |
| standard colonoscope first and G-EYEPatients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device) | Device | Arm A: Standard colonoscopy then colonoscopy with G-EYE |
Primary outcome
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Time frame: Colonoscopy time
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections
6 secondary outcomes
Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Time frame: Colonoscopy time
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female
Time frame: Colonoscopy time
Rate of complications
Time frame: Colonoscopy time and 1 month after
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup
Time frame: Colonoscopy time
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup
Time frame: Colonoscopy time
G-EYE assistance for endoscope stabilization
Time frame: Colonoscopy time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe RATONE, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-EYE first and standard colonoscope and standard colonoscope first and G-EYE in people with Colorectal Adenoma, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) (time frame: Colonoscopy time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.