As of February 13 2026 a clinical study evaluates the EndoR Surgical System for colorectal endoscopic submucosal dissection and related safety endpoints. The public record on ClinicalTrials.gov lists NCT07405203 and identifies the sponsor as the Chinese University of Hong Kong. The trial is described as active but not recruiting. This article explains what is publicly available and what regulators may consider as the device moves toward potential clinical use. The EndoR system is described in the study entry as a device applied to colorectal lesions within endoscopic submucosal dissection workflows. All statements reflect information from the ClinicalTrials.gov listing and the sponsor declaration only so far.
In this article
What changed in the EndoR System assessment?
Trial details
The ClinicalTrials.gov entry NCT07405203 lists an active not recruiting trial focused on the EndoR Surgical System for colorectal lesions. The sponsor is the Chinese University of Hong Kong. The listing confirms the scope and sponsor attribution described in the study title and sponsor field and signals ongoing oversight even before results are reported.
How the EndoR Surgical System is intended to be used for colorectal lesions?
The record shows the EndoR Surgical System in the intervention field and colorectal lesions in the condition field. The description places EndoR within endoscopic submucosal dissection workflows, suggesting a focus on device performance during dissection steps and potential safety endpoints related to the procedure.
What does the trial status indicate about safety and performance?
Active not recruiting status indicates that the study is not currently enrolling participants. This status often accompanies ongoing oversight protocol development or waiting for new opportunities to enroll. The listing does not yet present clinical results, so no safety or performance conclusions can be drawn from this entry alone.
What are regulatory implications for clinicians and sponsors?
Public records of this kind inform the regulatory interface and potential future submissions. The EndoR System is described as a device under investigation rather than a marketed product. Clinicians should monitor the ClinicalTrials.gov entry and sponsor communications for updates that may affect future use in practice. For sponsors the entry defines the scope of a potential regulatory path. A future submission would require comprehensive safety and performance data aligned with MDR expectations and device specific performance measures.
What evidence is expected to support regulatory decisions?
Regulatory review would rely on data from this trial and related studies. Evidence would address device performance in colorectal endoscopic submucosal dissection and any safety concerns arising during use on colorectal lesions. The current public record establishes the trial scope and status and forms the baseline for future data submissions.
- 1. What is EndoR used for in this trial? The study centers on colorectal lesions treated with endoscopic submucosal dissection using EndoR.
- 2. What is the study status? The study is listed as active but not recruiting.
- 3. Who funds the study? The sponsor is the Chinese University of Hong Kong.
- 4. Where is the study conducted? The listing provides sponsor and site level details in line with ClinicalTrials.gov records.
- 5. What is the scope of the trial? It covers device evaluation during colorectal lesion dissection with safety and performance endpoints.
In summary, the EndoR System is under clinical evaluation for colorectal lesions with a status of active not recruiting. Regulators and clinicians should await trial results and any formal submissions before drawing conclusions about safety or effectiveness.
Disclaimer: This article is for professional information. It is not legal advice. It reflects the public record as of February 2026.
https://clinicaltrials.gov/study/NCT07405203?term=medical+device