A novel single-use electronic colonoscope performs similarly as the conventional reusable system in terms of patient comfort, procedural outcomes, and safety, despite the inferior image quality, as shown in an exploratory randomized trial.
The single-use device was developed to address the risk of cross-contamination from reusable endoscopes, according to first author Dr Yuan Tian from Peking University First Hospital, Beijing, China, and colleagues.
“The intricate channels of conventional colonoscopes are exceptionally difficult to disinfect thoroughly. Microbial biofilms can persist despite strict reprocessing protocols,” Tian and colleagues pointed out.
Surveillance data from the US Food and Drug Administration indicate that up to 15 percent of reprocessed duodenoscopes retain culturable bacteria, which contribute to infection rates of 0.3 percent to 0.5 percent per procedure. [Modern Healthcare 2015;45:10]
“This poses a tangible threat, particularly in immunocompromised patients and during infectious disease outbreaks requiring rapid endoscope turnover,” they said.
In a randomized trial, Tian and colleagues enrolled 100 adults (mean age 54 years, 63 percent male) with indications for colonoscopy to undergo the procedure with either the single-use device (n=50) or a conventional system (Olympus CF-H260 colonoscope; n=50). All procedures were performed under conscious sedation.
Pivotal clinical endpoints were similar between the single-use device and the conventional system, the authors noted.
Real-time grip strength dynamometry assessment of patient comfort showed no significant differences in peak pain/maximum voluntary contraction ratio (p=0.852), cumulative pain (p=0.634) or average pain (p=0.783) during insertion, and cumulative pain (p=0.951) or average pain (p=0.945) throughout the procedure between the single-use and conventional colonoscope groups. [J Gastroenterol Hepatol 2026;41:1751-1759]
Cecal intubation was achieved in all participants, with mean cecal intubation time of 7.47 min with the single-use device vs 6.13 min with the conventional system (p=0.185). Complete endoscopic mucosal resection rate was 100 percent in both groups, and the mean procedure time was 11.32 min with the single-use device vs 11.57 min with the conventional system (p=0.899).
In terms of diagnostic performance, adenoma detection rate was 56 percent in the single-use group vs 60 percent in the conventional group (p=0.685). The mean number of adenomas per procedure was 1.06 vs 1.88, respectively (p=0.349). One sigmoid colon cancer was detected in each group.
However, image quality (p<0.001) and luminal far-field brightness/visualization (p<0.001) were significantly worse with the single-use vs conventional colonoscope.
There were no cases of intraoperative/postoperative bleeding during endoscopic mucosal resection, delayed postoperative bleeding, perforation, or instrument failure documented in either group.
“These preliminary findings support the potential [of a single-use colonoscope] for integration into clinical practice, particularly where sterility assurance and portability are paramount,” Tian and colleagues said. “Achieving optical parity with reusable endoscopes remains a paramount engineering challenge for widespread adoption in quality-sensitive screening programs.”
The next step in the research is to integrate imaging enhancements and confirm the noninferiority of the single-use colonoscope device, they added.