Trial Outcomes & Findings for i-Scan for the Detection of Helicobacter Pylori (NCT NCT02385045)

Results Overview

The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

157 participants

Primary outcome timeframe

1 year

Results posted on

2022-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Narrow Band Imaging Narrow band imaging function (Olympus endoscopes) narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes
Overall Study STARTED	157
Overall Study COMPLETED	153
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Narrow Band Imaging Narrow band imaging function (Olympus endoscopes) narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes
Overall Study Endoscopy could not be completed	4

Baseline Characteristics

i-Scan for the Detection of Helicobacter Pylori

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Narrow Band Imaging n=153 Participants Narrow band imaging function (Olympus endoscopes) narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=99 Participants
Age, Categorical >=65 years	47 Participants n=99 Participants
Age, Continuous	54.2 years STANDARD_DEVIATION 16.8 • n=99 Participants
Sex: Female, Male Female	87 Participants n=99 Participants
Sex: Female, Male Male	66 Participants n=99 Participants
Region of Enrollment United Kingdom	153 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All patients presenting for endoscopy who were recruited to the study.

The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques

Outcome measures

Outcome measures
Measure	Narrow Band Imaging n=153 Participants Narrow band imaging function (Olympus endoscopes) narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes
Successful Diagnosis of Helicobacter Pylori Using Imaging Modality H Pylori Positive	28 Participants
Successful Diagnosis of Helicobacter Pylori Using Imaging Modality H Pylori Negative	125 Participants

Adverse Events

Narrow Band Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Julian Teare

Imperial College London

Phone: 02033126666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place