Trial Outcomes & Findings for Post Market Evaluation of Aer-O-Scope Visualization (NCT NCT02926209)

NCT ID: NCT02926209

Last Updated: 2019-07-16

Results Overview

Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology. Three (3) lesions were missed by the Aer-OScope and detected with the subsequent conventional colonoscopy. Two (2) polyps were not removed and an additional one (1) was not retrieved. Data was missing for two (2) lesions by the Conventional Colonoscopy (CC)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: Through study completion, an average of one year
• Results posted on: 2019-07-16

Participant Flow

A total of 104 subjects were screened out of which 100 recruited into the study. Three (3) subjects were removed from the study by the physician during the procedures for medical reasons and one (1) subject did not complete the bowel preparation and was therefore excluded. One (1) subject withdrew consent prior to the procedure.

Participant milestones

Measure	Aer-O-Scope First Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope	Conventional Colonoscope First Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope
Study Cohort STARTED	42	37
Study Cohort COMPLETED	41	37
Study Cohort NOT COMPLETED	1	0
Training Cohort - First Patients STARTED	20	0
Training Cohort - First Patients COMPLETED	20	0
Training Cohort - First Patients NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Aer-O-Scope First Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope	Conventional Colonoscope First Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope
Study Cohort Poor Bowel Preparation	1	0

Baseline Characteristics

The first 20 participants were in the training cohort and were therefore not analyzed.

Baseline characteristics by cohort

Measure	Training Cohort n=98 Participants The first 20 subjects in this study were in the training cohort which was not evaluated statistically for the objectives.
Age, Customized Overall Total Subjects	55.41 years STANDARD_DEVIATION 5.84 • n=98 Participants • The first 20 participants were in the training cohort and were therefore not analyzed.
Age, Customized Study Cohort	55.33 years STANDARD_DEVIATION 5.99 • n=78 Participants • The first 20 participants were in the training cohort and were therefore not analyzed.
Sex: Female, Male Female	40 Participants n=98 Participants
Sex: Female, Male Male	58 Participants n=98 Participants
Region of Enrollment Israel	98 Participants n=98 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of one year

Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology.

Three (3) lesions were missed by the Aer-OScope and detected with the subsequent conventional colonoscopy. Two (2) polyps were not removed and an additional one (1) was not retrieved.

Data was missing for two (2) lesions by the Conventional Colonoscopy (CC)

Outcome measures

Measure	Aer-O-Scope First n=41 Participants Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope	Conventional Colonoscope First n=37 Participants Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope
Adenoma Miss Rates	3 missed adenomas	2 missed adenomas

SECONDARY outcome

Timeframe: Through study completion, an average of one year

Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass

Outcome measures

Measure	Aer-O-Scope First n=41 Participants Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope	Conventional Colonoscope First n=37 Participants Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope
Polyp Miss Rates (PMR) for Each Study Arm	4 missed polyps	2 missed polyps

SECONDARY outcome

Timeframe: Through study completion, an average of one year

Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology.

Outcome measures

Measure	Aer-O-Scope First n=41 Participants Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope	Conventional Colonoscope First n=37 Participants Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope Aer-O-Scope (Colonoscopy): Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope. Colonoscopy (Conventional Colonoscope): Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope
Advanced Adenoma Miss Rates (AAMR) for Each Study Arm	0 missed advanced adenomas	0 missed advanced adenomas

Adverse Events

Training Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aer-O-Scope First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Colonoscope First

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

CEO, Dr. Tal Simchony

GI View Ltd.

Phone: +97235753199

Email: tal@giview.com

Results disclosure agreements

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

Restriction type: LTE60