Colorectal Adenomatous PolypsNCT02811419
I-scan for Adenoma Detection
A study testing i-scan and standard high-definition white light in people with Colorectal Adenomatous Polyps, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenomatous Polyps
- What is being tested?
- i-scan and standard high-definition white light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-75
- Intact colon and rectum
- Willing to sign an informed consent form
Who cannot join
- Subjects less than 50 years of age or greater than 75 years of age
- Subjects who are in the inpatient unit
- Subjects with diverticulitis,
- Subjects with inflammatory bowel disease
- Subjects with polyposis syndromes
- Subjects with previous surgical resection of any portion of the colon or rectum
- Subjects referred for endoscopic resection of previously diagnosed colorectal polyp
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco Medical Center
San Francisco, California, 94115
About this study
Official title: I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps
This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps.
Read the detailed description
This is a randomized controlled trial comparing the use of i-scan (digital surface and contrast enhancement of the mucosa) versus standard high-definition white light for the detection of conventional adenomas and sessile serrated adenomas/polyps. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as sessile serrated adenomas/polyps (SSA) are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Recent studies have shown that image enhanced endoscopy can highlight the appearance of these lesions. This study will test whether i-scan increases the detection of conventional adenomas and sessile serrated adenomas/polyps in a randomized controlled trial.
- Conditions
- Colorectal Adenomatous Polyps
- Being tested
- i-scan, standard high-definition white light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-scanDevice
Also called colonoscopy
examination will be performed with i-scan digital enhancement
standard high-definition white lightDevice
Also called colonoscopy
examination will be performed with high-definition white light
| Study group | Role | What they receive |
|---|---|---|
| i-scan | Active comparator | Inspection with i-scan surface enhancement Receives: Device: i-scan |
| Standard high-definition white light | Active comparator | Inspection with standard high-definition white light (usual care) Receives: Device: standard high-definition white light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected
Measured: 12 months
Secondary outcomes (1)
Number of Participants With Conventional Adenoma Detected
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start1 Feb 2017
- Primary completion31 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey K Lee, MD, Principal investigator, Primary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811419
- Sponsor's protocol ID
- P072016
- Status last verified
- Apr 2019
- First submitted
- 21 Jun 2016
- Last updated
- 1 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kidambi TD, Terdiman JP, El-Nachef N, Singh A, Kattah MG, Lee JK. Effect of I-scan Electronic Chromoendoscopy on Detection of Adenomas During Colonoscopy. Clin Gastroenterol Hepatol. 2019 Mar;17(4):701-708.e1. doi: 10.1016/j.cgh.2018.06.024. Epub 2018 Jun 20.
PubMed 29935326
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps
- ClinicalTrials.gov ID
- NCT02811419
- Acronym / sponsor ID
- P072016
- Conditions
- Colorectal Adenomatous Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Posted 17 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps.
Detailed description
This is a randomized controlled trial comparing the use of i-scan (digital surface and contrast enhancement of the mucosa) versus standard high-definition white light for the detection of conventional adenomas and sessile serrated adenomas/polyps. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as sessile serrated adenomas/polyps (SSA) are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Recent studies have shown that image enhanced endoscopy can highlight the appearance of these lesions. This study will test whether i-scan increases the detection of conventional adenomas and sessile serrated adenomas/polyps in a randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-scan | Active comparator | Device: i-scanInspection with i-scan surface enhancement |
| Standard high-definition white light | Active comparator | Device: standard high-definition white lightInspection with standard high-definition white light (usual care) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-75
- Intact colon and rectum
- Willing to sign an informed consent form
Key exclusion criteria (7 listed)
- Subjects less than 50 years of age or greater than 75 years of age
- Subjects who are in the inpatient unit
- Subjects with diverticulitis,
- Subjects with inflammatory bowel disease
- Subjects with polyposis syndromes
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 |
|---|---|---|
| i-scanAlso: colonoscopyexamination will be performed with i-scan digital enhancement | Device | i-scan |
| standard high-definition white lightAlso: colonoscopyexamination will be performed with high-definition white light | Device | Standard high-definition white light |
Primary outcome
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected
Time frame: 12 months
1 secondary outcome
Number of Participants With Conventional Adenoma Detected
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29935326Kidambi TD, Terdiman JP, El-Nachef N, Singh A, Kattah MG, Lee JK. Effect of I-scan Electronic Chromoendoscopy on Detection of Adenomas During Colonoscopy. Clin Gastroenterol Hepatol. 2019 Mar;17(4):701-708.e1. doi: 10.1016/j.cgh.2018.06.024. Epub 2018 Jun 20.
- 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.
Jeffrey K Lee, MD principal investigator
Primary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-scan and standard high-definition white light in people with Colorectal Adenomatous Polyps, run by University of California, San Francisco 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 3 inclusion and 7 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 1 May 2019. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811419, which also lists 1 linked publication.
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 1 May 2019.