Colonic PolypNCT03949777
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
A study testing Aer-O-Scope Colonoscopy in people with Colonic Polyp and Colonic Neoplasms, run by GI View Ltd. at 1 site in Israel.
Trial summary
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colonic Neoplasms, Colonic Diseases
- What is being tested?
- Aer-O-Scope Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jan 2020to 14 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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
1 site in 1 country.
About this study
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
Read the detailed description
This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures.
Up to the first ten (10) cases for each physician will be system operation training cases.
The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.
- Conditions
- Colonic Polyp, Colonic Neoplasms, Colonic Diseases, Colon Adenoma, Colon Disease, Colon Adenocarcinoma
- Being tested
- Aer-O-Scope Colonoscopy
- Keywords
- screening-colonoscopy, diagnostic-colonoscopy, surveillance-colonoscopy
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aer-O-Scope ColonoscopyDevice
Also called therapeutic intervention - polyp resection
resection or biopsy of colonic abnormalities for histopathalogical evaluation
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Experimental | 61 subjects will undergo colonoscopy Receives: Device: Aer-O-Scope Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aer-O-Scope Validation of Cecal Intubation
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start6 Jan 2020
- Primary completion10 Aug 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI View Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan Gluck, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949777
- Sponsor's protocol ID
- 1056CLD
- Status last verified
- Aug 2021
- First submitted
- 28 Apr 2019
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Aer-O-Scope Colonoscope System Cecal Intubation
- ClinicalTrials.gov ID
- NCT03949777
- Acronym / sponsor ID
- 1056CLD
- Conditions
- Colonic Polyp, Colonic Neoplasms, Colonic Diseases, Colon Adenoma, Colon Disease, Colon Adenocarcinoma
- Keywords
- screening-colonoscopy, diagnostic-colonoscopy, surveillance-colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- GI View Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 14 Nov 2021 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
Detailed description
This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures.
Up to the first ten (10) cases for each physician will be system operation training cases.
The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | Experimental | Device: Aer-O-Scope Colonoscopy61 subjects will undergo colonoscopy |
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 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 ColonoscopyAlso: therapeutic intervention - polyp resectionresection or biopsy of colonic abnormalities for histopathalogical evaluation | Device | Study Cohort |
Primary outcome
Aer-O-Scope Validation of Cecal Intubation
Time frame: 30 minutes
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No. No individual patient data will be shared
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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.
Nathan Gluck, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aer-O-Scope Colonoscopy in people with Colonic Polyp and Colonic Neoplasms, run by GI View Ltd. at 1 site in Israel.
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: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Aer-O-Scope Validation of Cecal Intubation (time frame: 30 minutes). 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 18 Nov 2021.