Clinical trial · Interventional
Structured TXI-RDI Integration for Endoscopic Resection
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not funded
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endoscopic Mucosal Resection | — | UNRESOLVED | — |
| Polyp Colorectal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Definition White Light Endosocopy | Other | — | UNRESOLVED |
| Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TXI (Texture and Color Enhancement Imaging) Arm
- description
- 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.
- interventionNames
- Other: Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI)
- type
- ACTIVE_COMPARATOR
- label
- White Light (Control) Arm
- description
- 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.
- interventionNames
- Other: High Definition White Light Endosocopy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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