Colonic PolypsNCT02885987
Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
A study testing AmplifEYE in people with Colonic Polyps, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- AmplifEYE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to Mar 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.
Who cannot join
- Any pregnant patient
- Patient's that are unable to provide consent for themselves
- Any patient undergoing diagnostic colonoscopy (IBD, rectal bleeding, recent change in bowel habits, etc.)
- Any patient undergoing surveillance (prior history of polyps or colorectal cancer)
- Any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member <65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, PSC or IBD)
- Prior history of any cancer
Show all 13Show fewer
- Current or past immunosuppression (due to either infection or medications)
- Coagulation disorder OR use of anti-coagulation or anti-platelet therapy other than aspirin within 5-7 days of procedure
- Colonic strictures
- suspected intestinal obstruction or colonic pseudo-obstruction
- history of colon resection
- active infection
- active inflammation (including diverticulitis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.
- Conditions
- Colonic Polyps
- Being tested
- AmplifEYE
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmplifEYEDevice
Also called colonoscope accessory device
AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard Colonoscopy | No intervention | AmplifEYE will not be used. |
| Colonoscopy with AmplifEYE | Experimental | AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure Receives: Device: AmplifEYE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.
ADR is calculated by dividing the total number of screening procedures in which 1 or more histologically confirmed adenomas were detected by the total number of screening procedures performed.
Measured: 1 week
Secondary outcomes (11)
ADR will be differentiated according to morphology
ADR will be differentiated according to morphology (flat, sessile, pedunculated)
Measured: 1 week
ADR will be differentiated according to final pathology
ADR will be differentiated according to final pathology (sessile serrated adenomas, traditional serrated polyps, tubular/villous adenomas)
Measured: 1 week
ADR will be differentiated according to location
Location will be specified by colon segment and flexures.
Measured: 1 week
Advanced ADR
calculated as same for ADR, but only in those with polyps that are >=1 cm in size, with components of villous features, or with those of dysplasia
Measured: 1 week
Mean total number of polyps detected
calculated by dividing the total number of adenomas detected by the total number of screening procedures performed
Measured: 1 week
ADR-plus
mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected
Measured: 1 week
APP (adenomas per positive participant)
calculated as the total number of adenomas detected during the first colonoscopy divided by the number of positive participants (those with ≥1 adenoma detected during the first colonoscopy)
Measured: 1 week
APC (adenomas per colonoscopy)
calculated as the total number of adenomas detected during the first colonoscopy divided by the number of first colonoscopies
Measured: 1 week
Quality metrics: time of colonoscopy
Differences in quality metrics will be noted: cecal intubation time and total withdrawal time.
Measured: 1 hour
Quality metrics: prep quality
Differences in prep quality will be noted
Measured: 1 hour
Sedative Medications used
Differences in sedative medications used
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start3 Aug 2017
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: decided not to go ahead with study at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Jahng, MD, Loma Linda University
- Investigators
- Alexander Jahng, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885987
- Sponsor's protocol ID
- 5160326
- Status last verified
- Oct 2020
- First submitted
- 8 Jul 2016
- Last updated
- 20 Oct 2020
- 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 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
- ClinicalTrials.gov ID
- NCT02885987
- Acronym / sponsor ID
- 5160326
- Conditions
- Colonic Polyps
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: decided not to go ahead with study at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- 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.
The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Colonoscopy | No intervention | –AmplifEYE will not be used. |
| Colonoscopy with AmplifEYE | Experimental | Device: AmplifEYEAmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.
Key exclusion criteria (13 listed)
- Any pregnant patient
- Patient's that are unable to provide consent for themselves
- Any patient undergoing diagnostic colonoscopy (IBD, rectal bleeding, recent change in bowel habits, etc.)
- Any patient undergoing surveillance (prior history of polyps or colorectal cancer)
- Any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member <65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, PSC or IBD)
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 |
|---|---|---|
| AmplifEYEAlso: colonoscope accessory deviceAmplifEYE will be attached to the tip of the colonoscope prior to start of procedure. | Device | Colonoscopy with AmplifEYE |
Primary outcome
Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.
Time frame: 1 week
ADR is calculated by dividing the total number of screening procedures in which 1 or more histologically confirmed adenomas were detected by the total number of screening procedures performed.
11 secondary outcomes
ADR will be differentiated according to morphology
Time frame: 1 week
ADR will be differentiated according to final pathology
Time frame: 1 week
ADR will be differentiated according to location
Time frame: 1 week
Advanced ADR
Time frame: 1 week
Mean total number of polyps detected
Time frame: 1 week
ADR-plus
Time frame: 1 week
APP (adenomas per positive participant)
Time frame: 1 week
APC (adenomas per colonoscopy)
Time frame: 1 week
Quality metrics: time of colonoscopy
Time frame: 1 hour
Quality metrics: prep quality
Time frame: 1 hour
Sedative Medications used
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Colonic Polyps
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
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.
Alexander Jahng, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AmplifEYE in people with Colonic Polyps, run by Loma Linda University at 1 site in United States.
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 1 inclusion and 13 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: withdrawn, as of the sponsor's last update on 20 Oct 2020. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Difference in adenoma detection rate (ADR), with and without use of AmplifEYE. (time frame: 1 week). 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 20 Oct 2020.