Endorail in Long Lasting Colonoscopy

Colonoscopy Clinical Trial

Official title: Multicenter Clinical Trial for the Evaluation of Safety and Effectiveness of Endorail in Patients With Long-lasting Colonoscopy

Status Completed

Clinical Trial Summary

Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Endorail works as a magnetic anchor that is able to guide the colonoscope and to straighten colon curves and loops. The aim of this study is to test the safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75 years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time greater than 10 minutes will take part in the study. The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety endpoints are the absence of device-related serious adverse events and the evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.

Clinical Trial Description

Patients with long lasting colonoscopy are characterized by higher risk of incompletion. A colonoscopy can be defined as incomplete when the endoscopist cannot reach the caecum. Caecal intubation is one of the main goals of colonoscopy and represents a diagnostic quality indicator. International guidelines recommend caecal intubation rates ≥90% for all colonoscopies in daily clinical practice. Reported incomplete colonoscopy rates range from 4% to 25%. Caecal intubation fails in 4-10% of cases in tertiary referred centres, instead in national surveys colonoscopies are incomplete in 10-25% of cases.

Endorail is a medical device intended to facilitate the positioning of a standard colonoscope. Endorail is a colonoscopy add-on device that works as a magnetic anchor able to guide the colonoscope and to straighten colon curves and loops.

Endorail is composed by the following two CE marked medical devices: Endorail Set and Endorail System. Endorail Set consists of the Endorail Balloon Guide, The Endorail Solution Syringe, The Endorail Powder and the Spike. Endorail System consists of the Endorail Handpiece and the Endorail Cart.

The aim of this study is to test the safety and efficacy of the Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold.

Outpatients of either sex aged between 22-75 years, undergoing elective colonoscopy for diagnostic or surveillance colonoscopy, who have signed a written informed consent and presenting caecal intubation time greater than 10 minutes, will take part in the study. The study plan will include a screening/baseline/treatment visit (Visit 1/Day 1), during which colonoscopy with the investigational medical device Endorail will be performed and a phone follow-up visit (Visit 2), scheduled at 7 (± 1) day after treatment with the investigational medical device Endorail.

The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies

The primary safety endpoints are:

• The absence of device-related serious adverse events. AND

• The evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail. ;

Related Conditions & MeSH terms

• Colonoscopy
• Incomplete Colonoscopy

• NCT number: NCT05626738
• Study type: Interventional
• Source: Endostart srl
• Status: Completed
• Phase: N/A
• Start date: January 25, 2023
• Completion date: July 24, 2023