USER EVALUATIONS OF THE DEVICE PERFORMANCE OF A NOVEL SINGLE-USE DUODENOSCOPE IN A CLINICAL SETTING

Aims To investigate endoscopists’ perception of a novel single-use duodenoscope (SUD) in clinical use.

Methods Performance evaluation forms were filled by 137 European and Australian endoscopists at 87 hospitals immediately after using the SUD (Ambu aScope Duodeno) in patients for the first time. A five-point Likert scale was used to assess the attributes of the SUD. Whether they would use the SUD again was assessed on a binary scale, and comments on the translucent tip were segmented based on their theme. The ASGE ERCP difficulty grading scale and endoscopists’ SUD experience were assessed using linear regression. Statistical analysis was done with RStudio Pro ver. 1.2.5033-1.

Results In 247 procedures, the endoscopists median overall satisfaction with the SUD was 4 (IQR 3-4). 98% would use the SUD again. 82% commented positively on the translucent tip. Median score for ease of setup, silent suction button and the weight of the endoscope were “above expectations” in 37%, 39% and 36%, respectively. Median scores of remaining parameters were “meets expectations”. The overall satisfaction, navigation, angulation capability, tip control and orientation and passing of accessories correlated significantly (P>0.05) with the endoscopists’ experience with the SUD. ASGE ERCP grading scale correlated with rating of weight and ease of setup.

Table 1

Expectation (Overall Satisfaction)	Far below / Below (1) / (2)	Meets (3)	Above (4)	Far above (5)
Ease of setup	0% / 1%	45%	37%	16%
Silent suction Button	1% / 6%	33%	39%	21%
Weight of SUD	1% / 2%	40%	36%	20%
Overall Satisfaction	0% / 8%	32%	47%	13%

Conclusions The majority of endoscopist were satisfied with performance of the SUD with median ratings stated as “meets expectations” or above. 98% were willing to use the SUD again. Positive comments on the translucent tip indicates that further research is needed to fully understand the benefits and clinical implications.

Publication History

Article published online:
14 April 2022