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Trial Outcomes & Findings for Endorail in Long Lasting Colonoscopy (NCT NCT05626738)

NCT ID: NCT05626738

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

day 1

Results posted on

2024-09-19

Participant Flow

Trial Initiation Date: 25 January 2023 Trial Completion Date: 25 July 2023 Coordinating / Principal Investigator: * IRCCS Humanitas Research Hospital, Via Manzoni 56, I-20089 Rozzano (Milan, Italy). PI: Prof. Alessandro Repici. * GastroZentrum Lippe, Lange Str.55, Bad Salzuflen (Germany). PI: Prof. Helmut Neumann * University Hospitals Leuven. Herestraat 49, B-3000 Leuven (Belgium). PI: Prof. Raf Bisschops

Participant milestones

Participant milestones
Measure
Long-lasting Colonoscopy With Endorail
In case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure.
Overall Study
STARTED
38
Overall Study
COMPLETED
38
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Long-lasting Colonoscopy With Endorail
n=38 Participants
In case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure.
Age, Categorical
<=18 years
0 Participants
n=38 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=38 Participants
Age, Categorical
>=65 years
0 Participants
n=38 Participants
Age, Continuous
57.7 years
STANDARD_DEVIATION 10.1 • n=38 Participants
Sex: Female, Male
Female
19 Participants
n=38 Participants
Sex: Female, Male
Male
19 Participants
n=38 Participants
Region of Enrollment
Belgium
2 participants
n=38 Participants
Region of Enrollment
Italy
21 participants
n=38 Participants
Region of Enrollment
Germany
15 participants
n=38 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Long-lasting Colonoscopy With Endorail
n=38 Participants
In case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure.
Percentage of Incomplete Long-lasting Colonscopies
0 % of participants

PRIMARY outcome

Timeframe: day 1

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

Outcome measures

Outcome measures
Measure
Long-lasting Colonoscopy With Endorail
n=38 Participants
In case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure.
Number of Device-related Serious Adverse Events
0 Number of Device-related SAE

PRIMARY outcome

Timeframe: day 7

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

Outcome measures

Outcome measures
Measure
Long-lasting Colonoscopy With Endorail
n=36 Participants
In case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure.
Number of Device-related Serious Adverse Events
0 Number of Device-related SAE

Adverse Events

Long-lasting Colonoscopy With Endorail

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Long-lasting Colonoscopy With Endorail
n=38 participants at risk
In case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure.
Gastrointestinal disorders
Hypogastric pain
2.6%
1/38 • Number of events 1 • 7 days
Gastrointestinal disorders
Hemorroidal plexus infiam-mation
2.6%
1/38 • Number of events 1 • 7 days
General disorders
Seasonal allergy
2.6%
1/38 • Number of events 1 • 7 days

Additional Information

Alessandro Tozzi

ENDOSTART SRL

Phone: 0571843033

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place