Structured TXI-RDI Integration for Endoscopic Resection

NCT07474844 | Withdrawn

• 1 other identifier: PRO00056730
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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; Adenoma Recurrence; Feasibility Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adenoma Recurrence

  At first surveillance colonoscopy (typically 6-12 months post-EMR).

• Endoscopist-Rated Visualization and Workflow Satisfaction

  Immediately after each EMR procedure.

Study Arms (2)

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.

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.

Other: High Definition White Light Endosocopy

Interventions

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

TXI (Texture and Color Enhancement Imaging) Arm

High Definition White Light Endosocopy OTHER

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.

White Light (Control) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zachary L Smith, DO, MSc.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: March 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.