Evaluating the performance of single-use duodenoscopes in gastrointestinal procedures
Single-USe Duodenoscopes PErformance Characteristics and Technical Outcomes: the SUSPECT Italian Prospective Study
This study is testing how well single-use duodenoscopes work for patients undergoing procedures to treat gastrointestinal issues, to see if they can help reduce the risk of infections compared to reusable ones.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milano) |
| Trial ID | NCT05735678 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance characteristics and technical outcomes of single-use duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) for treating gastrointestinal tract diseases. The study will involve patients who are scheduled for clinically indicated ERCP or other duodenoscope-based procedures. By focusing on single-use devices, the study seeks to address concerns regarding infection transmission associated with reusable duodenoscopes. Participants will be monitored for outcomes related to the use of these devices in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who require an ERCP or similar procedure.
Not a fit: Patients who are pregnant or have contraindications to endoscopic techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infections associated with duodenoscope procedures.
How similar studies have performed: While there have been studies on duodenoscope safety, the focus on single-use devices represents a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Willing and able to comply with the study procedures and provide written informed consent to participate in the study * Schedule for a clinically indicated ERCP or other duodenoscope-based procedure Exclusion Criteria: * Potentially vulnerable subjects, including, but not limited to pregnant women * Subjects for whom endoscopic techniques are contraindicated * Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
Where this trial is running
Rozzano, Milano
- Department of Gastroenterology, Humanitas Research Hospital — Rozzano, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Repici, MD
- Email: alessandro.repici@humanitas.it
- Phone: 0039-02-82247493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.