NCT05626738

Endorail in Long Lasting Colonoscopy

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing ENDORAIL in Colonoscopy in 38 participants. Completed in 24 July 2023.

Timeline

25 January 2023

Primary endpoint
24 May 2023

24 July 2023

Quick facts

Lead sponsor	Endostart srl
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	38
Start date	25 January 2023
Primary completion	24 May 2023
Estimated completion	24 July 2023
Sites	3 locations across Belgium, Italy, Germany

Drugs / interventions tested

• ENDORAIL

Conditions studied

• Colonoscopy — all drugs for Colonoscopy →
• Incomplete Colonoscopy — all drugs for Incomplete Colonoscopy →

Sponsor

Endostart srl

Who can join

Adults 22 to 75, any sex, with Colonoscopy or Incomplete Colonoscopy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Incomplete Long-lasting Colonscopies Primary · day 1

Colonoscopy is defined completed when caecal intubation is achieved. Colonoscopy is defined long-lasting when caecal intubation time is longer than 10 minutes. The percentage of incomplete long-lasting colonscopies is calculated as the ratio, in percetange, between the number of incomplete long-lasting colonscopies and the total number of patients enrolled.

Group	Value	95% CI
Long-lasting Colonoscopy With Endorail	0

Number of Device-related Serious Adverse Events Primary · day 1

Number of the device-related serious adverse events collected at day 1 visit

Group	Value	95% CI
Long-lasting Colonoscopy With Endorail	0

Number of Device-related Serious Adverse Events Primary · day 7

Number of device-related serious adverse events collected through phone call at day 7.

Group	Value	95% CI
Long-lasting Colonoscopy With Endorail	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Long-lasting Colonoscopy With Endorail

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (3 terms — click to expand)

Reaction	System	Long-lasting Colonoscopy W…
Hypogastric pain	Gastrointestinal disorders	—
Hemorroidal plexus infiam-mation	Gastrointestinal disorders	—
Seasonal allergy	General disorders	—

Data from ClinicalTrials.gov NCT05626738 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Robotic Colonoscopy and Beyond: Insights into Modern Lower Gastrointestinal Endoscopy.
   Tumino E, Visaggi P, Bolognesi V, Ceccarelli L, et al · · 2023 · cited 6× · PMID 37510196 · DOI 10.3390/diagnostics13142452
2. Painless colonoscopy: fact or fiction?
   Sinonquel P, Jans A, Bisschops R. · · 2024 · cited 5× · PMID 38932703 · DOI 10.5946/ce.2024.001