# Evaluating the clinical use and safety of LumenEye in an outpatient colorectal clinic: a single-centre retrospective cohort study

## TL;DR

LumenEye is a safe and practical outpatient tool for rectal cancer monitoring, offering high-resolution visualization and biopsy capability without sedation.

## Contribution

The study evaluates LumenEye's safety and feasibility in a novel outpatient clinic for watch-and-wait rectal cancer patients.

## Key findings

- LumenEye was well tolerated with minimal complications such as pain and minor bleeding.
- No perforations or infections occurred during the 327 procedures evaluated.
- LumenEye is proposed as a viable alternative to traditional endoscopy for rectal cancer monitoring.

## Abstract

Digital rectoscopy may reduce demand on endoscopy units, particularly as part of a watch-and-wait (WAW) organ preservation strategy for rectal cancer. LumenEye is a digital rigid rectoscope offering high-resolution rectal visualisation, video streaming and biopsy capability without sedation. This study aimed to evaluate the safety and feasibility of LumenEye in a novel outpatient colorectal clinic primarily managing WAW patients.

A single centre, retrospective analysis of all patients who underwent a LumenEye examination in this clinic between August 2023 and November 2024 was conducted. Demographic, procedural, referral and outcome data were collected from electronic health records. Descriptive statistics summarised findings, while chi-squared and logistic regression analyses identified factors associated with complications or early termination.

A total of 327 procedures were performed; mean patient age was 67.6 years. Most procedures (54.1%, n = 177) were for WAW patients, with 52.6% of referrals originating from the colorectal multidisciplinary team. LumenEye was generally well tolerated: pain requiring analgesia occurred in 5.8% (n = 19), early termination in 2.1% (n = 7) and minor bleeding in 1.2% (n = 4). No perforations or infections occurred. One local cancer recurrence (0.3%) was missed and subsequently identified on flexible sigmoidoscopy 3 months later. Pain and bleeding were significant predictors of early termination (p < 0.001).

LumenEye is a safe and practical tool for outpatient rectal examination including patients with rectal cancer undergoing WAW organ preservation strategy. Its minimal support requirements and favourable safety profile suggest that it may be a valuable alternative to traditional endoscopy, particularly in settings where access is limited.

The online version contains supplementary material available at 10.1007/s10151-025-03279-0.