Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial

Area of Science:

• Gastroenterology
• Medical Devices
• Infection Control

Background:

• Reusable gastroscopes pose a risk of infection transmission.
• Disposable gastroscopes have been developed to mitigate this risk.
• This study compares the performance of disposable versus reusable gastroscopes.

Purpose of the Study:

• To evaluate the noninferiority of disposable gastroscopes compared to reusable ones.
• To assess various technical performance factors and safety profiles.
• To determine the suitability of disposable gastroscopes for routine gastrointestinal examinations.

Main Methods:

• A randomized controlled trial involving 110 patients undergoing gastroscopy.
• Patients were assigned to either a disposable or reusable digital gastroscope group.
• Primary endpoint: success rate of imaging key anatomical sites; secondary endpoints: imaging quality, maneuverability, completion rate, device failure, operating time, and safety.

Main Results:

• Both disposable and reusable gastroscopes achieved a 100% success rate in image capture.
• Disposable gastroscopes had significantly lower average imaging quality scores and longer operating times.
• No significant differences were observed in maneuverability, completion rates, device failure rates, or safety between the two groups.

Conclusions:

• Disposable gastroscopes demonstrate comparable technical performance and safety to reusable ones.
• They are a viable alternative for routine examinations, emergency procedures, and specific clinical situations.
• The use of disposable gastroscopes can enhance infection control in gastrointestinal endoscopy.