Post-endoscopic Mucosal Resection of Colon PolypsNCT02668198
Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods
A study testing Olympus CF190 Colonoscope High definition white light, Olympus CF190 Colonoscope White light with near focus and Olympus CF190 Colonoscope Narrow band imaging in people with Post-endoscopic Mucosal Resection of Colon Polyps, run by Michael Wallace at 1 site in United States.
Trial summary
The purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic tissue at site of prior EMR Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-endoscopic Mucosal Resection of Colon Polyps
- What is being tested?
- Olympus CF190 Colonoscope High definition white light, Olympus CF190 Colonoscope White light with near focus and Olympus CF190 Colonoscope Narrow band imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-EMR follow up at 6-12 months
Who cannot join
- Non-corrected coagulopathy
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Using Colonoscope With Near Focus Capability in Detecting Residual Colorectal Neoplastic Tissue After Endoscopic Mucosal Resection (EMR): a Prospective Study
The purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic tissue at site of prior EMR
Read the detailed description
Residual neoplasia after EMR is a common. Optimal surveillance protocols are not clearly defined. There is a need for better imaging modalities to evaluate for residual disease. Suspected residual tissue can be confirmed with repeat colonoscopy or can be empirically treated. However, this can lead to either frequent colonoscopy or overtreatment. This presents more cost and financial burden to the patient. With the introduction of newer colonoscopes that have near focus/zoom capability, it is important to assess whether the near focus technology offers better accuracy for detection of residual neoplastic tissue. With better accuracy to confidently rule out residual neoplasia using newer imaging modality, additional treatment or biopsy at the previous EMR may be avoided. Furthermore, the interval for surveillance colonoscopy can be lengthened.
- Being tested
- Olympus CF190 Colonoscope High definition white light, Olympus CF190 Colonoscope White light with near focus, Olympus CF190 Colonoscope Narrow band imaging, Olympus CF190 Colonoscope Narrow band imaging with near focus, Biopsy
- Keywords
- Endoscopic mucosal resection, residual polyp, near focus imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus CF190 Colonoscope High definition white lightDevice
Standard endoscopic imaging technique
Olympus CF190 Colonoscope White light with near focusDevice
Near focus mode is used to closely examine the area of prior EMR site.
Olympus CF190 Colonoscope Narrow band imagingDevice
Narrow band imaging is utilized to examine the area of prior EMR.
Olympus CF190 Colonoscope Narrow band imaging with near focusDevice
NBI with near focus to help closely examine the area of prior EMR site.
BiopsyProcedure or surgery
Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic scar assessment | Experimental | Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus. Receives: Device: Olympus CF190 Colonoscope High definition white light; Device: Olympus CF190 Colonoscope White light with near focus; Device: Olympus CF190 Colonoscope Narrow band imaging; Device: Olympus CF190 Colonoscope Narrow band imaging with near focus; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Recurrent Adenomas Using White Light Imaging
The number of positive diagnoses using white light optical imaging only.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology
The number of recurrent adenomas diagnosed positive with white light imaging confirmed by standard histopathology of biopsy.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using White Light Near Focus Imaging
The number of positive diagnoses using white light near focus optical imaging only.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology
The number of recurrent adenomas diagnosed positive with white light imaging near focus confirmed by standard histopathology of biopsy.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using Narrow Band Imaging
The number of positive diagnoses using narrow band optical imaging only.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology
The number of recurrent adenomas diagnosed positive with narrow band imaging confirmed by standard histopathology of biopsy.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus
The number of positive diagnoses using narrow band optical imaging near focus only.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology
The number of recurrent adenomas diagnosed positive with narrow band imaging near focus confirmed by standard histopathology of biopsy.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Positive Recurrent Adenomas Using Biopsy
The number of positive diagnoses determined by standard histopathology assessment of biopsy.
Measured: approximately 6 to 12 months post endoscopic mucosal resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2018
- Study completionOct 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 Post-endoscopic Mucosal Resection of Colon PolypsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Wallace
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus America, Inc.
- Responsible party
- Sponsor-investigator, Michael Wallace, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668198
- Sponsor's protocol ID
- 15-007241
- Status last verified
- Sep 2019
- First submitted
- 23 Jan 2016
- Last updated
- 17 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.
PubMed 30635409
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Using Colonoscope With Near Focus Capability in Detecting Residual Colorectal Neoplastic Tissue After Endoscopic Mucosal Resection (EMR): a Prospective Study
- ClinicalTrials.gov ID
- NCT02668198
- Acronym / sponsor ID
- 15-007241
- Keywords
- Endoscopic mucosal resection, residual polyp, near focus imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Michael WallaceUniversity, hospital or other
- Collaborators
- Olympus America, Inc.
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 17 Oct 2019
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 study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic tissue at site of prior EMR
Detailed description
Residual neoplasia after EMR is a common. Optimal surveillance protocols are not clearly defined. There is a need for better imaging modalities to evaluate for residual disease. Suspected residual tissue can be confirmed with repeat colonoscopy or can be empirically treated. However, this can lead to either frequent colonoscopy or overtreatment. This presents more cost and financial burden to the patient. With the introduction of newer colonoscopes that have near focus/zoom capability, it is important to assess whether the near focus technology offers better accuracy for detection of residual neoplastic tissue. With better accuracy to confidently rule out residual neoplasia using newer imaging modality, additional treatment or biopsy at the previous EMR may be avoided. Furthermore, the interval for surveillance colonoscopy can be lengthened.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic scar assessment | Experimental | Device: Olympus CF190 Colonoscope High definition white light, Device: Olympus CF190 Colonoscope White light with near focus, Device: Olympus CF190 Colonoscope Narrow band imaging, Device: Olympus CF190 Colonoscope Narrow band imaging with near focus, Procedure: BiopsyUsing endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-EMR follow up at 6-12 months
Key exclusion criteria (3 listed)
- Non-corrected coagulopathy
- Pregnancy
- Breast feeding
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 |
|---|---|---|
| Olympus CF190 Colonoscope High definition white lightStandard endoscopic imaging technique | Device | Endoscopic scar assessment |
| Olympus CF190 Colonoscope White light with near focusNear focus mode is used to closely examine the area of prior EMR site. | Device | Endoscopic scar assessment |
| Olympus CF190 Colonoscope Narrow band imagingNarrow band imaging is utilized to examine the area of prior EMR. | Device | Endoscopic scar assessment |
| Olympus CF190 Colonoscope Narrow band imaging with near focusNBI with near focus to help closely examine the area of prior EMR site. | Device | Endoscopic scar assessment |
| BiopsyBiopsy to assess any evidence of residual neoplasia via standard histopathology assessment | Procedure or surgery | Endoscopic scar assessment |
Primary outcome
Positive Recurrent Adenomas Using White Light Imaging
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using white light optical imaging only.
Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with white light imaging confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using White Light Near Focus Imaging
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using white light near focus optical imaging only.
Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with white light imaging near focus confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using Narrow Band Imaging
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using narrow band optical imaging only.
Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with narrow band imaging confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using narrow band optical imaging near focus only.
Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with narrow band imaging near focus confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using Biopsy
Time frame: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses determined by standard histopathology assessment of biopsy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30635409Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olympus CF190 Colonoscope High definition white light, Olympus CF190 Colonoscope White light with near focus and Olympus CF190 Colonoscope Narrow band imaging in people with Post-endoscopic Mucosal Resection of Colon Polyps, run by Michael Wallace 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 3 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 17 Oct 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 Oct 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?
Positive Recurrent Adenomas Using White Light Imaging (time frame: approximately 6 to 12 months post endoscopic mucosal resection). The study lists 9 primary outcomes in all. 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 NCT02668198, 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 17 Oct 2019.