Polyp ColorectalSTRIkERNCT07474844
Structured TXI-RDI Integration for Endoscopic Resection
A study testing Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI) and High Definition White Light Endosocopy in people with Polyp Colorectal and Endoscopic Mucosal Resection, run by Medical College of Wisconsin.
Trial summary
The goal of this clinical research study is to learn whether two advanced imaging tools, called Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI), can make the removal of large colon polyps safer, faster, and more effective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyp Colorectal, Endoscopic Mucosal Resection
- What is being tested?
- Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI) and High Definition White Light Endosocopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Undergoing elective colonoscopy at the Medical College of Wisconsin.
- Presence of one or more large (≥20 mm) nonpedunculated colorectal polyps identified for endoscopic mucosal resection (EMR).
- EMR performed using an Olympus EVIS X1 endoscopy platform with TXI and RDI imaging capability.
- Able and willing to provide written informed consent for study participation, including collection of procedural imaging and clinical follow-up dat
Who cannot join
- Procedures performed using older-generation endoscopy systems without TXI or RDI functionality.
- Polyps that are pedunculated, invasive, or require surgical resection rather than EMR.
- Patients unable or unwilling to provide consent for participation or video capture.
- Known pregnancy at the time of procedure.
- Patients incarcerated or under custodial supervision.
- Inability to tolerate bowel preparation, sedation, or standard EMR procedure due to comorbid conditions.
- Incomplete colonoscopy or procedure aborted prior to resection for any reason.
About this study
Official title: Structured TXI-RDI Integration for Endoscopic Resection (STRIkER): A Prospective, Two-Part Clinical Study Evaluating the Feasibility and Clinical Utility of TXI and RDI Imaging Modalities During Endoscopic Mucosal Resection of Large Colorectal Polyps
The goal of this clinical research study is to learn whether two advanced imaging tools, called Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI), can make the removal of large colon polyps safer, faster, and more effective. These tools are built into the Olympus EVIS X1 endoscopy system and are already approved for use in standard colonoscopy. TXI helps enhance the surface detail and color contrast of the colon lining, while RDI improves visibility of deeper blood vessels. The study is testing how these imaging modes can be used in a structured way to guide endoscopic mucosal resection (EMR), a non-surgical technique that removes large, precancerous polyps from the colon.
Large or complex colon polyps can sometimes turn into cancer if they are not completely removed. EMR is an important alternative to surgery because it allows these growths to be removed through the colonoscope, reducing recovery time and risk. However, two problems still occur in some cases: incomplete removal of the polyp, which can lead to recurrence, and delayed bleeding after the procedure. STRIkER aims to see whether using TXI and RDI in a structured workflow can lower these risks and improve the overall quality of the procedure.
Read more
This is a prospective, single-center study taking place at the Medical College of Wisconsin. It includes two parts. The first is a randomized controlled trial comparing EMR performed with TXI versus standard high-definition white light. The goal is to determine whether TXI shortens the time needed to remove a polyp and improves visualization during resection. The second part is an observational study that uses RDI after EMR to examine the resection area for blood vessels or other features that might predict delayed bleeding. In this arm, researchers will evaluate whether certain visual features seen with RDI are linked to a higher risk of bleeding after the procedure.
Adults aged 18 years or older who are undergoing colonoscopy for removal of one or more large (20 millimeter or larger), nonpedunculated colon polyps may take part. Participants will receive standard clinical care, including bowel preparation, colonoscopy, and post-procedure monitoring. During the colonoscopy, the endoscopist will use either TXI or standard white light during the polyp removal phase, depending on random assignment. After removal, RDI may be used to inspect the resection area. Photos and short video clips may be collected for research review, but all images will be de-identified and stored securely. No experimental drugs or devices are used in this study, and there are no additional procedures beyond the standard colonoscopy and EMR.
Participants will have follow-up through the existing clinical workflow. A routine phone call will occur within a few days after the procedure to check for any early side effects or bleeding. For those in the RDI portion of the study, medical records will be reviewed about 30 days after the procedure to look for any delayed bleeding or unplanned visits. Participants in the TXI portion will have their standard follow-up colonoscopy, usually around six months after the initial procedure, to check whether any tissue has grown back at the site.
The information from this study will help researchers understand how image-enhanced endoscopy can be applied in real-world settings to make complex colon polyp removal safer and more reliable. If TXI and RDI improve visualization and reduce complications without adding risk or cost, this approach could be easily adopted by hospitals already using Olympus equipment. The long-term goal is to develop larger, multicenter studies and eventually establish standardized, image-guided protocols that help prevent colorectal cancer more effectively through high-quality endoscopic resection.
Read the detailed description
The Structured TXI-RDI Integration for Endoscopic Resection (STRIkER) study is a single-center, prospective research project evaluating the real-world feasibility and clinical utility of two image-enhanced endoscopy modes-Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI)-during endoscopic mucosal resection (EMR) of large colorectal polyps. The study is conducted at the Medical College of Wisconsin through the Wisconsin Institute for Research in Endoscopy (WIRE).
The trial is designed in two complementary parts. The first component is a randomized controlled trial comparing EMR performed with TXI versus standard high-definition white light imaging. This pilot aims to assess procedural efficiency, measured primarily by total resection time, as well as indicators of visualization quality and workflow integration. The second component is an observational cohort evaluating the use of RDI after EMR to examine the resection base for vascular features that may be linked to delayed post-polypectomy bleeding. Both components are conducted using standard, FDA-cleared Olympus EVIS X1 endoscopy systems currently in clinical use.
Participants will be adults undergoing elective colonoscopy with EMR for large (≥20 mm), nonpedunculated colorectal polyps. During the procedure, those in the TXI randomized arm will have their imaging mode assigned 1:1 to either TXI or white light. In both arms, RDI may be applied immediately after resection to inspect the resection base, and representative still images or brief video segments will be collected and de-identified for later analysis. No investigational drugs, devices, or invasive techniques are introduced. All procedures, sedation, and post-procedure care follow routine clinical standards.
Data will be prospectively entered into a secure REDCap database and include procedural metrics, image quality assessments, and follow-up outcomes. For the TXI arm, follow-up extends through the participant's next surveillance colonoscopy to assess adenoma recurrence. For the RDI arm, clinical follow-up continues through 30 days post-procedure to identify delayed bleeding events requiring medical intervention.
The STRIkER study focuses on feasibility, safety, and workflow adherence rather than definitive hypothesis testing. Its objectives are to confirm that TXI and RDI can be systematically integrated into EMR practice, to estimate their potential impact on procedure time and bleeding outcomes, and to generate pilot data for future multicenter trials. Because both imaging modes are software-based tools already available on standard Olympus platforms, successful demonstration of benefit could enable rapid and cost-neutral implementation across endoscopy units.
This project aligns with ongoing institutional efforts to improve non-surgical colorectal cancer prevention through standardized, image-enhanced endoscopic techniques. Findings from STRIkER will inform the design of a larger, multicenter study evaluating the effect of TXI and RDI on recurrence, safety, and overall EMR quality.
- Conditions
- Polyp Colorectal, Endoscopic Mucosal Resection
- Being tested
- Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI), High Definition White Light Endosocopy
- Keywords
- Endoscopic Mucosal Resection, Colon Polyps, Colorectal Cancer Prevention, Image-Enhanced Endoscopy, Texture and Color Enhancement Imaging (TXI), Red Dichromatic Imaging (RDI), Olympus EVIS X1, Post-Polypectomy Bleeding, Adenoma Recurrence, Feasibility Study
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI)Other
Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI) are software-based visualization modes integrated into the Olympus EVIS X1 endoscopy system. These FDA-cleared imaging technologies enhance mucosal and vascular visualization during standard colonoscopy without introducing any new devices or physical interventions.
In the randomized TXI arm, TXI is used as the primary imaging mode during endoscopic mucosal resection (EMR) of large (≥20 mm), nonpedunculated colorectal polyps. TXI improves surface contrast and color tone to help define polyp borders and assess residual tissue.
In the control arm, high-definition white light imaging is used for EMR following the same procedural workflow.
In the observational RDI arm, RDI is activated immediately after EMR to inspect the resection base for visible blood vessels or other features that may indicate bleeding risk. RDI enhances visualization of submucosal vasculature using filtered red, amber, and green wavelength
High Definition White Light EndosocopyOther
White Light Endoscopy (WLE) represents the standard imaging mode used during routine colonoscopy and endoscopic mucosal resection (EMR). In this study, WLE serves as the control condition for comparison with Texture and Color Enhancement Imaging (TXI).
Participants randomized to the WLE arm will undergo EMR of large (≥20 mm), nonpedunculated colorectal polyps using conventional high-definition white light on the Olympus EVIS X1 endoscopy system. All other procedural elements-including equipment, resection technique, sedation, and data collection-will follow identical protocols to those used in the TXI arm.
WLE provides natural color visualization of the mucosal surface without digital enhancement or image processing. It is the current standard of care for EMR and is included in this study to establish baseline performance measures for resection time, visualization quality, and recurrence rates compared to TXI-assisted imaging.
| Study group | Role | What they receive |
|---|---|---|
| TXI (Texture and Color Enhancement Imaging) Arm | Experimental | Participants undergoing endoscopic mucosal resection (EMR) for large (≥20 mm) nonpedunculated colorectal polyps will be randomized to have the procedure performed using TXI imaging mode on the Olympus EVIS X1 system. TXI enhances mucosal texture and color contrast to improve visualization during resection. Receives: Other: Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI) |
| White Light (Control) Arm | Active comparator | Participants undergoing EMR will be randomized to have the procedure performed using standard high-definition white light imaging. All other aspects of the procedure will follow identical protocols to the TXI arm. Receives: Other: High Definition White Light Endosocopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Resection Time (TXI vs. White Light)
Total resection time (in minutes) measured from snare deployment to complete removal of the target polyp during endoscopic mucosal resection (EMR). This measure evaluates whether TXI improves procedural efficiency compared to standard white light imaging.
Measured: During EMR procedure (Day 0).
Secondary outcomes (2)
Adenoma Recurrence
Incidence of overt recurrent adenomatous tissue at the original EMR site (histologic confirmation is not required), identified during surveillance colonoscopy.
Measured: At first surveillance colonoscopy (typically 6-12 months post-EMR).
Endoscopist-Rated Visualization and Workflow Satisfaction
The rate of endoscopist satisfaction of visualization quality, ease of identifying lesion margins, and overall workflow satisfaction following EMR using TXI or RDI, measured using standardized post-procedure survey instruments (1-5 Lickert scale).
Measured: Immediately after each EMR procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp ColorectalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The STRIkER study includes two complementary components conducted in parallel. The first is a randomized controlled trial (RCT) comparing endoscopic mucosal resection (EMR) performed with Texture and Color Enhancement Imaging (TXI) versus standard high-definition white light imaging. Participants are randomized 1:1 to one of these imaging modalities during the resection phase. In parallel, an observational cohort uses Red Dichromatic Imaging (RDI) immediately after EMR to evaluate the resection base for vascular features associated with delayed bleeding. Both components share the same participant pool and standardized workflow but address distinct scientific questions within a single coordinated study framework.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zachary L Smith, DO, MSc., Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474844
- Sponsor's protocol ID
- PRO00056730
- Acronym
- STRIkER
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) may be shared upon reasonable request after publication of primary study results. Shared data will include key procedural variables, imaging-derived metrics, and clinical outcomes such as resection time, delayed bleeding, and recurrence status. No personally identifiable information, images containing patient identifiers, or protected health information will be shared. Access will be provided to qualified researchers for noncommercial scientific purposes upon submission of a written proposal and data use agreement approved by the Medical College of Wisconsin.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured TXI-RDI Integration for Endoscopic Resection (STRIkER): A Prospective, Two-Part Clinical Study Evaluating the Feasibility and Clinical Utility of TXI and RDI Imaging Modalities During Endoscopic Mucosal Resection of Large Colorectal Polyps
- ClinicalTrials.gov ID
- NCT07474844
- Acronym / sponsor ID
- STRIkER / PRO00056730
- Conditions
- Polyp Colorectal, Endoscopic Mucosal Resection
- Keywords
- Endoscopic Mucosal Resection, Colon Polyps, Colorectal Cancer Prevention, Image-Enhanced Endoscopy, Texture and Color Enhancement Imaging (TXI), Red Dichromatic Imaging (RDI), Olympus EVIS X1, Post-Polypectomy Bleeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
The goal of this clinical research study is to learn whether two advanced imaging tools, called Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI), can make the removal of large colon polyps safer, faster, and more effective. These tools are built into the Olympus EVIS X1 endoscopy system and are already approved for use in standard colonoscopy. TXI helps enhance the surface detail and color contrast of the colon lining, while RDI improves visibility of deeper blood vessels. The study is testing how these imaging modes can be used in a structured way to guide endoscopic mucosal resection (EMR), a non-surgical technique that removes large, precancerous polyps from the colon.
Large or complex colon polyps can sometimes turn into cancer if they are not completely removed. EMR is an important alternative to surgery because it allows these growths to be removed through the colonoscope, reducing recovery time and risk. However, two problems still occur in some cases: incomplete removal of the polyp, which can lead to recurrence, and delayed bleeding after the procedure. STRIkER aims to see whether using TXI and RDI in a structured workflow can lower these risks and improve the overall quality of the procedure.
This is a prospective, single-center study taking place at the Medical College of Wisconsin. It includes two parts. The first is a randomized controlled trial comparing EMR performed with TXI versus standard high-definition white light. The goal is to determine whether TXI shortens the time needed to remove a polyp and improves visualization during resection. The second part is an observational study that uses RDI after EMR to examine the resection area for blood vessels or other features that might predict delayed bleeding. In this arm, researchers will evaluate whether certain visual features seen with RDI are linked to a higher risk of bleeding after the procedure.
Adults aged 18 years or older who are undergoing colonoscopy for removal of one or more large (20 millimeter or larger), nonpedunculated colon polyps may take part. Participants will receive standard clinical care, including bowel preparation, colonoscopy, and post-procedure monitoring. During the colonoscopy, the endoscopist will use either TXI or standard white light during the polyp removal phase, depending on random assignment. After removal, RDI may be used to inspect the resection area. Photos and short video clips may be collected for research review, but all images will be de-identified and stored securely. No experimental drugs or devices are used in this study, and there are no additional procedures beyond the standard colonoscopy and EMR.
Participants will have follow-up through the existing clinical workflow. A routine phone call will occur within a few days after the procedure to check for any early side effects or bleeding. For those in the RDI portion of the study, medical records will be reviewed about 30 days after the procedure to look for any delayed bleeding or unplanned visits. Participants in the TXI portion will have their standard follow-up colonoscopy, usually around six months after the initial procedure, to check whether any tissue has grown back at the site.
The information from this study will help researchers understand how image-enhanced endoscopy can be applied in real-world settings to make complex colon polyp removal safer and more reliable. If TXI and RDI improve visualization and reduce complications without adding risk or cost, this approach could be easily adopted by hospitals already using Olympus equipment. The long-term goal is to develop larger, multicenter studies and eventually establish standardized, image-guided protocols that help prevent colorectal cancer more effectively through high-quality endoscopic resection.
Detailed description
The Structured TXI-RDI Integration for Endoscopic Resection (STRIkER) study is a single-center, prospective research project evaluating the real-world feasibility and clinical utility of two image-enhanced endoscopy modes-Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI)-during endoscopic mucosal resection (EMR) of large colorectal polyps. The study is conducted at the Medical College of Wisconsin through the Wisconsin Institute for Research in Endoscopy (WIRE).
The trial is designed in two complementary parts. The first component is a randomized controlled trial comparing EMR performed with TXI versus standard high-definition white light imaging. This pilot aims to assess procedural efficiency, measured primarily by total resection time, as well as indicators of visualization quality and workflow integration. The second component is an observational cohort evaluating the use of RDI after EMR to examine the resection base for vascular features that may be linked to delayed post-polypectomy bleeding. Both components are conducted using standard, FDA-cleared Olympus EVIS X1 endoscopy systems currently in clinical use.
Participants will be adults undergoing elective colonoscopy with EMR for large (≥20 mm), nonpedunculated colorectal polyps. During the procedure, those in the TXI randomized arm will have their imaging mode assigned 1:1 to either TXI or white light. In both arms, RDI may be applied immediately after resection to inspect the resection base, and representative still images or brief video segments will be collected and de-identified for later analysis. No investigational drugs, devices, or invasive techniques are introduced. All procedures, sedation, and post-procedure care follow routine clinical standards.
Data will be prospectively entered into a secure REDCap database and include procedural metrics, image quality assessments, and follow-up outcomes. For the TXI arm, follow-up extends through the participant's next surveillance colonoscopy to assess adenoma recurrence. For the RDI arm, clinical follow-up continues through 30 days post-procedure to identify delayed bleeding events requiring medical intervention.
The STRIkER study focuses on feasibility, safety, and workflow adherence rather than definitive hypothesis testing. Its objectives are to confirm that TXI and RDI can be systematically integrated into EMR practice, to estimate their potential impact on procedure time and bleeding outcomes, and to generate pilot data for future multicenter trials. Because both imaging modes are software-based tools already available on standard Olympus platforms, successful demonstration of benefit could enable rapid and cost-neutral implementation across endoscopy units.
This project aligns with ongoing institutional efforts to improve non-surgical colorectal cancer prevention through standardized, image-enhanced endoscopic techniques. Findings from STRIkER will inform the design of a larger, multicenter study evaluating the effect of TXI and RDI on recurrence, safety, and overall EMR quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The STRIkER study includes two complementary components conducted in parallel. The first is a randomized controlled trial (RCT) comparing endoscopic mucosal resection (EMR) performed with Texture and Color Enhancement Imaging (TXI) versus standard high-definition white light imaging. Participants are randomized 1:1 to one of these imaging modalities during the resection phase. In parallel, an observational cohort uses Red Dichromatic Imaging (RDI) immediately after EMR to evaluate the resection base for vascular features associated with delayed bleeding. Both components share the same participant pool and standardized workflow but address distinct scientific questions within a single coordinated study framework.
| Arm | Type | Receives |
|---|---|---|
| TXI (Texture and Color Enhancement Imaging) Arm | Experimental | Other: Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI)Participants undergoing endoscopic mucosal resection (EMR) for large (≥20 mm) nonpedunculated colorectal polyps will be randomized to have the procedure performed using TXI imaging mode on the Olympus EVIS X1 system. TXI enhances mucosal texture and color contrast to improve visualization during resection. |
| White Light (Control) Arm | Active comparator | Other: High Definition White Light EndosocopyParticipants undergoing EMR will be randomized to have the procedure performed using standard high-definition white light imaging. All other aspects of the procedure will follow identical protocols to the TXI arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Undergoing elective colonoscopy at the Medical College of Wisconsin.
- Presence of one or more large (≥20 mm) nonpedunculated colorectal polyps identified for endoscopic mucosal resection (EMR).
- EMR performed using an Olympus EVIS X1 endoscopy platform with TXI and RDI imaging capability.
- Able and willing to provide written informed consent for study participation, including collection of procedural imaging and clinical follow-up dat
Key exclusion criteria (7 listed)
- Procedures performed using older-generation endoscopy systems without TXI or RDI functionality.
- Polyps that are pedunculated, invasive, or require surgical resection rather than EMR.
- Patients unable or unwilling to provide consent for participation or video capture.
- Known pregnancy at the time of procedure.
- Patients incarcerated or under custodial supervision.
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 |
|---|---|---|
| Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI)Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI) are software-based visualization modes integrated into the Olympus EVIS X1 endoscopy system. These FDA-cleared imaging technologies enhance mucosal and vascular visualization during standard colonoscopy without introducing any new devices or physical interventions. In the randomized TXI arm, TXI is used as the primary imaging mode during endoscopic mucosal resection (EMR) of large (≥20 mm), nonpedunculated colorectal polyps. TXI improves surface contrast and color tone to help define polyp borders and assess residual tissue. In the control arm, high-definition white light imaging is used for EMR following the same procedural workflow. In the observational RDI arm, RDI is activated immediately after EMR to inspect the resection base for visible blood vessels or other features that may indicate bleeding risk. RDI enhances visualization of submucosal vasculature using filtered red, amber, and green wavelength | Other | TXI (Texture and Color Enhancement Imaging) Arm |
| High Definition White Light EndosocopyWhite Light Endoscopy (WLE) represents the standard imaging mode used during routine colonoscopy and endoscopic mucosal resection (EMR). In this study, WLE serves as the control condition for comparison with Texture and Color Enhancement Imaging (TXI). Participants randomized to the WLE arm will undergo EMR of large (≥20 mm), nonpedunculated colorectal polyps using conventional high-definition white light on the Olympus EVIS X1 endoscopy system. All other procedural elements-including equipment, resection technique, sedation, and data collection-will follow identical protocols to those used in the TXI arm. WLE provides natural color visualization of the mucosal surface without digital enhancement or image processing. It is the current standard of care for EMR and is included in this study to establish baseline performance measures for resection time, visualization quality, and recurrence rates compared to TXI-assisted imaging. | Other | White Light (Control) Arm |
Primary outcome
Total Resection Time (TXI vs. White Light)
Time frame: During EMR procedure (Day 0).
Total resection time (in minutes) measured from snare deployment to complete removal of the target polyp during endoscopic mucosal resection (EMR). This measure evaluates whether TXI improves procedural efficiency compared to standard white light imaging.
2 secondary outcomes
Adenoma Recurrence
Time frame: At first surveillance colonoscopy (typically 6-12 months post-EMR).
Endoscopist-Rated Visualization and Workflow Satisfaction
Time frame: Immediately after each EMR procedure.
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 16 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) may be shared upon reasonable request after publication of primary study results. Shared data will include key procedural variables, imaging-derived metrics, and clinical outcomes such as resection time, delayed bleeding, and recurrence status. No personally identifiable information, images containing patient identifiers, or protected health information will be shared. Access will be provided to qualified researchers for noncommercial scientific purposes upon submission of a written proposal and data use agreement approved by the Medical College of Wisconsin.
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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.
Zachary L Smith, DO, MSc. principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
A study testing Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI) and High Definition White Light Endosocopy in people with Polyp Colorectal and Endoscopic Mucosal Resection, run by Medical College of Wisconsin.
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 5 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: withdrawn, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Total Resection Time (TXI vs. White Light) (time frame: During EMR procedure (Day 0).). 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 16 Mar 2026.