Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05626738
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2022-11-08
Brief Title:
Endorail in Long Lasting Colonoscopy
Sponsor:
Endostart srl
Organization:
Endostart srl
Study Overview
Official Title:
Multicenter Clinical Trial for the Evaluation of Safety and Effectiveness of Endorail in Patients With Long-lasting Colonoscopy
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 screeningbaselinetreatment visit Visit 1Day 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
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 screeningbaselinetreatment visit Visit 1Day 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None