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Endoscopy
DOI: 10.1055/a-2760-4729
Editorial

Single-use gastroscopes: evolution postponed

Referring to Römmele C et al. doi: 10.1055/a-2735-1114

Authors

  • Enrique Rodriguez de Santiago 

    1   Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Madrid, Spain (Ringgold ID: RIN16507)
    2   Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
    3   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
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10.1055/a-2735-1114

When the first single-use gastroscope (SUG) entered the European market, it provoked mixed reactions within the endoscopy community. Some regarded it as a welcome innovation, promising convenience and safety; others questioned whether disposability could ever align with performance, cost, and sustainability. After the uncontrolled One-Scope I pilot study by the same research group [1], we reflected in a previous Endoscopy editorial on whether SUGs represented an evolution, a revolution, or an involution [2]. Several months later, with the first randomized trial now available, we may begin to answer that question with evidence rather than intuition.

In this issue of Endoscopy, Römmele and colleagues report a prospective, randomized noninferiority trial comparing SUGs and reusable gastroscopes (RUGs) for upper gastrointestinal bleeding (UGIB) [3]. Complete visualization of all upper GI landmarks with a conclusive assessment regarding the presence of a bleeding source was achieved in 97.3% of cases with SUGs and 95.9% with RUGs, meeting the prespecified 10% noninferiority margin. This result provides reassurance that disposable gastroscopes can deliver acceptable diagnostic performance in this emergency setting. Yet, beneath the reassuring primary outcome lie some worrying secondary findings that are probably more clinically relevant. The bleeding site was identified significantly less frequently in the SUG group (68.9% vs. 83.8%), the rate of intensive-care admissions was higher (51.5% vs. 31.8%), and there was a trend toward more repeated gastroscopies. In addition, user experience was rated significantly higher in all assessed categories for RUGs, confirming that the optical performance and maneuverability of single-use models still have room for improvement.

“True innovation will emerge not from disposability, but from a balanced integration of safety, efficiency, and environmental responsibility.”

From a methodologic standpoint, this trial represents an important and carefully executed step forward. The investigators designed a pragmatic, single-center, open-label, noninferiority study; however, a few aspects merit cautious interpretation. The 10% noninferiority margin – though standard in device evaluations – was not explicitly justified from a clinical perspective and might be considered generous for a life-saving procedure. Randomization by sealed envelopes immediately before the intervention provided operational simplicity, but not full allocation concealment. The block size was not reported as being concealed, which could have compromised allocation concealment if investigators were able to predict the next assignment once they knew the block length. The open-label nature of the study, combined with a subjective primary end point based on the endoscopist’s assessment of “complete visualization,” introduces potential bias that is difficult to avoid in device research. These are not major flaws, but they illustrate the challenges of designing and interpreting noninferiority trials of new technologies in endoscopy. Despite these limitations, the authors should be commended for their approach and novelty.

Another telling detail lies in the crossovers: 5/74 patients (6.8%) assigned to the single-use arm required conversion to an RUG because of poor visibility or failed intervention. This proportion corresponds to a 95%CI of approximately 2.9% to 14.9%, an upper boundary that would be difficult to accept in clinical practice. If these five crossovers were counted as failures in their originally assigned group – hypothetically assuming that the device did not fulfil its real clinical function – the success rate for the SUGs would drop from 97.3% to 90.5%, compared with 95.9% for RUGs. This yields an absolute difference of −5.4 percentage points (Newcombe 95%CI −16.9 to +6.6 percentage points), with the lower confidence limit crossing the predefined noninferiority margin of −10%. Under this stricter assumption, noninferiority could no longer be formally demonstrated. This emphasizes how a small number of procedural failures can meaningfully alter statistical conclusions and, more importantly, highlights the current fragility of SUGs in fulfilling their intended purpose during emergency endoscopy.

The rationale for single-use devices has largely rested on infection control. While this argument may carry some weight for complex duodenoscopes, it is far less compelling in gastroscopy, where infection risk after proper reprocessing of devices is exceedingly low. Pursuing absolute sterility at the expense of environmental sustainability may therefore represent a disproportionate response to a minimal threat. The challenge is not eliminating an already very rare risk, but balancing safety, sustainability, and practicality. We already know that the carbon footprint of an SUG is 2.5-fold higher compared with RUGs, even when reprocessing is considered [4]. Their environmental impact extends across the entire life cycle – from raw-material extraction to manufacturing, packaging, and disposal. The paradox is evident: a device designed to prevent microscopic infection risks contributes to macroscopic environmental harm. In an era where healthcare’s contribution to greenhouse-gas emissions is under scrutiny, sustainability can no longer be an afterthought.

Several questions remain open after this randomized trial. No patient or public involvement was included, missing an opportunity to understand how patients perceive SUGs – and whether they value their convenience over the environmental consequences. Similarly, a cost-effectiveness analysis would have provided crucial context, as disposable endoscopes remove reprocessing costs but generate ongoing material expenditure. Including these aspects in future work would help clarify not only whether SUGs work, but also whether they are truly worth it.

So, are we witnessing evolution, revolution, or involution? Revolution, certainly not, and we see no convincing signs of evolution either. The study by Römmele and colleagues highlights that feasibility does not equal clinical equivalence. Despite achieving formal noninferiority, the clinical performance, user experience, and reliability of current single-use models remain inferior, with a higher environmental impact and uncertain economic implications. With the present technology, SUGs seem to add no tangible benefit over reusable systems.

In conclusion, the current recommendations from the European Society of Gastrointestinal Endoscopy and the British Society of Gastroenterology, which advise against the routine use of single-use endoscopes, remain appropriate [5] [6]. SUGs offer no demonstrable clinical or operational advantage, while adding environmental burden. Any proposal to replace RUGs must therefore rest on the strongest possible evidence, not including only noninferiority designs, but also demanding superiority trials for clinically relevant outcomes. True innovation will emerge not from disposability, but from a balanced integration of safety, efficiency, and environmental responsibility.



Publication History

Article published online:
22 December 2025

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Refers to:

Single-use versus reusable gastroscopes for the initial assessment of patients with upper gastrointestinal bleeding: a prospective randomized noninferiority trialEndoscopy eFirst
DOI: 10.1055/a-2735-1114