CancerNCT02926209
Post Market Evaluation of Aer-O-Scope Visualization
A study testing Aer-O-Scope (Colonoscopy) and Colonoscopy (Conventional Colonoscope) in people with Cancer, run by GI View Ltd. at 2 sites in 2 countries.
Trial summary
This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Aer-O-Scope (Colonoscopy) and Colonoscopy (Conventional Colonoscope)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Feb 2017to 11 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
- Subject willing to undergo tandem colonoscopies with Aer-O-Scope Colonoscope and a conventional colonoscope (including a single colon preparation bowel cleansing)
- Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
- Subject is able to understand and willing to sign informed consent form
Who cannot join
- Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
- Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
- Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
- History of colonic resection
- Clinically significant cardiovascular or pulmonary disease.
- Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
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- Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
- Pregnancy
- Previous radiation therapy to the abdomen
- Morbid Obesity (BMI > 40 kg/m2)
- Drug abuse or alcoholism
- Subject is bed-ridden and/or unable to adequately communicate
- Subject is under custodial care
- Subject has a history of psychiatric disorders which would prevent compliance with study instructions
- Participation in a clinical study within the previous 30 days
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.
Read the detailed description
Subjects will be randomized in blocks of twenty (20) for either Aer-O-Scope or conventional colonoscopy as the first procedure. Physicians will be notified of the procedural order immediately prior to first colonoscopy. Up to the first ten (10) cases for each physician (system operation training cases) will all begin with the Aer-O-Scope colonoscopy as the first procedure.
The primary endpoint of AMR was chosen as this measure appears to be related to the performance of colonoscopy and reduction in colorectal cancer incidence. During the course of the last decade, several major visualizations studies have been performed and it has become common practice to use the "second-pass" method for measuring colonoscopy visualization methods, iii, iv. In the "second-pass" method, during the course of the first colonoscopy, all visualized lesions are removed (or tattooed in the event that they cannot be removed for any reason.). Any unmarked abnormalities discovered during the second pass colonoscopy are considered to be missed pathologies for the first pass colonoscopy.
All endpoints related to timing will be measured using a stopwatch and overall time stamp from the Aer-O-Scope or conventional colonoscope. Time to perform therapeutic interventions with Aer-O-Scope as well as a description of said interventions will also be recorded. The same instruments will be used to measure all procedures and will be calibrated as dictated by the manufacturer.
All equipment used during the course of this clinical investigation will undergo calibration and testing as per the manufacturing instructions. The Aer-O-Scope Colonoscope System has an automated calibration system and diagnostic test that run daily. Conventional colonoscopes will be maintained as per hospital/manufacturer protocol.
Recruited subjects who are withdrawn as a result of poor bowel prep or any other medical determination leading to the inability to undergo colonoscopy and/or tandem colonoscopy will be replaced. A poor prep is defined as having a score of score of 0 or 1 in the Boston Bowel Preparation Scale (BBPS). The BBPS scores are as follows:
0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
- = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
- = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
- = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Any subject withdrawn as a result of physician discretion due to concomitant medical issues will be withdrawn prior to the actual colonoscopic procedures. Patients with a large polyp (>20mm) removed during the first pass with a conventional colonoscope will be withdrawn. Patients who receive treatment during the first pass with clips (no other option available) will be withdrawn.
Coagulation therapy should be performed either with Argon Plasma Coagulation (APC) or another cautery tool or contact thermal device as per clinical protocol. For the purpose of this clinical investigation, clips should not be used unless there is no alternative. Patients treated with clips prior to their final pass colonoscopy, will be withdrawn from the investigation.
Physicians may also withdraw any patient due to medical causes if deemed appropriate, including patients that have undergone at least one (1) procedure.
- Conditions
- Cancer
- Being tested
- Aer-O-Scope (Colonoscopy), Colonoscopy (Conventional Colonoscope)
- Keywords
- colonoscopy, adenoma, polyp, crc screening
- Medical subject headings
- Neoplasms, Adenoma, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aer-O-Scope (Colonoscopy)Device
Also called CRC Screening
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)Procedure or surgery
Also called CRC Screening
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 group | Role | What they receive |
|---|---|---|
| Aer-O-Scope First | Active comparator | Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope Receives: Device: Aer-O-Scope (Colonoscopy); Procedure: Colonoscopy (Conventional Colonoscope) |
| Conventional Colonoscope First | Active comparator | Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope Receives: Device: Aer-O-Scope (Colonoscopy); Procedure: Colonoscopy (Conventional Colonoscope) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Miss Rates
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)
Measured: Through study completion, an average of one year
Secondary outcomes (2)
Polyp Miss Rates (PMR) for Each Study Arm
Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass
Measured: Through study completion, an average of one year
Advanced Adenoma Miss Rates (AAMR) for Each Study Arm
Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start21 Feb 2017
- Primary completion8 Nov 2017
- Study completion11 Apr 2018
Why it stopped: Further development needed to facilitate easier polypectomy - device improvement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI View Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erwin Santo, MD, Principal investigator, Tel Aviv Souraski Medical Center, IsraelKlaus Mergener, MD, PhD, MBA, Principal investigator, Waldron Endoscopy Center, Tacoma, WA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926209
- Sponsor's protocol ID
- 934CLD
- Status last verified
- Jun 2019
- First submitted
- 27 Sep 2016
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Evaluation of Aer-O-Scope Visualization
- ClinicalTrials.gov ID
- NCT02926209
- Acronym / sponsor ID
- 934CLD
- Conditions
- Cancer
- Keywords
- colonoscopy, adenoma, polyp, crc screening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Further development needed to facilitate easier polypectomy - device improvement
- Enrolment
- 104 participants (actual)
- Lead sponsor
- GI View Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.
Detailed description
Subjects will be randomized in blocks of twenty (20) for either Aer-O-Scope or conventional colonoscopy as the first procedure. Physicians will be notified of the procedural order immediately prior to first colonoscopy. Up to the first ten (10) cases for each physician (system operation training cases) will all begin with the Aer-O-Scope colonoscopy as the first procedure.
The primary endpoint of AMR was chosen as this measure appears to be related to the performance of colonoscopy and reduction in colorectal cancer incidence. During the course of the last decade, several major visualizations studies have been performed and it has become common practice to use the "second-pass" method for measuring colonoscopy visualization methods, iii, iv. In the "second-pass" method, during the course of the first colonoscopy, all visualized lesions are removed (or tattooed in the event that they cannot be removed for any reason.). Any unmarked abnormalities discovered during the second pass colonoscopy are considered to be missed pathologies for the first pass colonoscopy.
All endpoints related to timing will be measured using a stopwatch and overall time stamp from the Aer-O-Scope or conventional colonoscope. Time to perform therapeutic interventions with Aer-O-Scope as well as a description of said interventions will also be recorded. The same instruments will be used to measure all procedures and will be calibrated as dictated by the manufacturer.
All equipment used during the course of this clinical investigation will undergo calibration and testing as per the manufacturing instructions. The Aer-O-Scope Colonoscope System has an automated calibration system and diagnostic test that run daily. Conventional colonoscopes will be maintained as per hospital/manufacturer protocol.
Recruited subjects who are withdrawn as a result of poor bowel prep or any other medical determination leading to the inability to undergo colonoscopy and/or tandem colonoscopy will be replaced. A poor prep is defined as having a score of score of 0 or 1 in the Boston Bowel Preparation Scale (BBPS). The BBPS scores are as follows:
0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
- = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
- = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
- = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Any subject withdrawn as a result of physician discretion due to concomitant medical issues will be withdrawn prior to the actual colonoscopic procedures. Patients with a large polyp (>20mm) removed during the first pass with a conventional colonoscope will be withdrawn. Patients who receive treatment during the first pass with clips (no other option available) will be withdrawn.
Coagulation therapy should be performed either with Argon Plasma Coagulation (APC) or another cautery tool or contact thermal device as per clinical protocol. For the purpose of this clinical investigation, clips should not be used unless there is no alternative. Patients treated with clips prior to their final pass colonoscopy, will be withdrawn from the investigation.
Physicians may also withdraw any patient due to medical causes if deemed appropriate, including patients that have undergone at least one (1) procedure.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aer-O-Scope First | Active comparator | Device: Aer-O-Scope (Colonoscopy), Procedure: Colonoscopy (Conventional Colonoscope)Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope |
| Conventional Colonoscope First | Active comparator | Device: Aer-O-Scope (Colonoscopy), Procedure: Colonoscopy (Conventional Colonoscope)Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
- Subject willing to undergo tandem colonoscopies with Aer-O-Scope Colonoscope and a conventional colonoscope (including a single colon preparation bowel cleansing)
- Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
- Subject is able to understand and willing to sign informed consent form
Key exclusion criteria (15 listed)
- Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
- Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
- Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
- History of colonic resection
- Clinically significant cardiovascular or pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aer-O-Scope (Colonoscopy)Also: CRC ScreeningPatients 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. | Device | Aer-O-Scope First, Conventional Colonoscope First |
| Colonoscopy (Conventional Colonoscope)Also: CRC ScreeningPatients 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 | Procedure or surgery | Aer-O-Scope First, Conventional Colonoscope First |
Primary outcome
Adenoma Miss Rates
Time frame: 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)
2 secondary outcomes
Polyp Miss Rates (PMR) for Each Study Arm
Time frame: Through study completion, an average of one year
Advanced Adenoma Miss Rates (AAMR) for Each Study Arm
Time frame: Through study completion, an average of one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin Santo, MD principal investigator
Tel Aviv Souraski Medical Center, Israel
Klaus Mergener, MD, PhD, MBA principal investigator
Waldron Endoscopy Center, Tacoma, WA, USA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aer-O-Scope (Colonoscopy) and Colonoscopy (Conventional Colonoscope) in people with Cancer, run by GI View Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Miss Rates (time frame: Through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.