Structured TXI-RDI Integration for Endoscopic Resection (STRIkER)

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Polyp Colorectal; Endoscopic Mucosal Resection
• Intervention / Treatment: Other: Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI); Other: High Definition White Light Endosocopy

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TXI (Texture and Color Enhancement Imaging) Arm; 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.	Other: 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
Active Comparator: White Light (Control) Arm; 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.	Other: High Definition White Light Endosocopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During EMR procedure (Day 0).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Recurrence	Incidence of overt recurrent adenomatous tissue at the original EMR site (histologic confirmation is not required), identified during surveillance colonoscopy.	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).	Immediately after each EMR procedure.

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Zachary L Smith, DO, MSc., Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopic Mucosal Resection; Feasibility Study; Colon Polyps; Adenoma Recurrence; Colorectal Cancer Prevention; Image-Enhanced Endoscopy; Texture and Color Enhancement Imaging (TXI); Red Dichromatic Imaging (RDI); Olympus EVIS X1; Post-Polypectomy Bleeding
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Pathological Conditions, Signs and Symptoms; Colonic Polyps
• Other Study ID Numbers: PRO00056730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: De-identified individual participant data will be available beginning 6 months after publication of the primary results and will remain accessible for up to 10 years following publication or until the STRIkER data repository is retired, whichever occurs first.
• IPD Sharing Access Criteria: Qualified researchers affiliated with academic, nonprofit, or government institutions may request access to the de-identified dataset and supporting documentation. Requests must include a brief research proposal outlining study aims and analysis plans. Access will be granted after review and approval by the principal investigator and the Medical College of Wisconsin data governance committee. Approved users must sign a data use agreement specifying that data will be used only for noncommercial, IRB-approved research purposes and that reidentification or redistribution of data is prohibited. Data will be shared through a secure, HIPAA-compliant electronic transfer platform.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No