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Endorail in Long Lasting Colonoscopy

NCT05626738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Colonoscopy
  • Incomplete Colonoscopy

Interventions

DEVICE

ENDORAIL

In case caecal intubation time is longer than 10 minutes, the balloon catheter is inserted in the tool channel, advanced beyond the colonoscope tip and filled with Ferromagnetic Fluid. By applying the Endorail Handpiece over the patient abdomen, the balloon can be magnetically anchored. The anchored balloon guide allows to straighten the scope and the colon itself. The colonoscope can thus be easily moved back and forward along the anchored guide to facilitate colonoscope positioning and colonoscopy completion. Afterward, Endorail is removed and the straightened colonoscope can be easily pushed forward to achieve colonoscopy completion according to standard endoscopic technique.

Sponsors & Collaborators

  • Endostart srl

    lead INDUSTRY

Principal Investigators

  • Alessandro F Ferri · Advice Pharma Group S.r.l.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2023-05-24
Completion
2023-07-24

Countries

  • Belgium
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626738 on ClinicalTrials.gov