Colon CancerNCT00867724
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
A study testing Aer-O-Scope Colonoscopy in people with Colon Cancer and Rectal Cancer, run by GI View Ltd. at 1 site in Israel.
Trial summary
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- 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
- 68 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Jul 2013
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 and 70 years of age
- Patients who are generally healthy and classified as low risk for CRC
- Patients who are ready to undergo standard colonoscopy examination including colon prep.
- Signed informed consent
Who cannot join
- Patients with any known GI related symptoms complaints or GI diseases
- Patients with cancer or other life threatening diseases or conditions
- Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study).
- Pregnant women
- Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
- Morbid Obesity (BMI > 40)
Show all 11Show fewer
- Drug abuse or alcoholism
- Bed-ridden patient
- Inadequate communication with the patient
- Patients under custodial care
- Participation in current clinical study or clinical study within 30 days prior to the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.
Read the detailed description
Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Aer-O-Scope Colonoscopy
- Keywords
- polyp
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Polyps
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 Aer-O-Scope
Screening Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Aer-O-Scope Colonoscopy | Experimental | Screening Colonoscopy Receives: Device: Aer-O-Scope Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to screen the entire length of the colon to the cecum.
Measured: 30 -60 minutes
Secondary outcomes (1)
Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI View Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erwin M Santo, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867724
- Sponsor's protocol ID
- 190-CLD-AOS
- Status last verified
- Jul 2017
- First submitted
- 23 Mar 2009
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects
- ClinicalTrials.gov ID
- NCT00867724
- Acronym / sponsor ID
- 190-CLD-AOS
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- GI View Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Mar 2009 (estimated)
- 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.
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.
Detailed description
Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aer-O-Scope Colonoscopy | Experimental | Device: Aer-O-Scope ColonoscopyScreening Colonoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients between 18 and 70 years of age
- Patients who are generally healthy and classified as low risk for CRC
- Patients who are ready to undergo standard colonoscopy examination including colon prep.
- Signed informed consent
Key exclusion criteria (11 listed)
- Patients with any known GI related symptoms complaints or GI diseases
- Patients with cancer or other life threatening diseases or conditions
- Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study).
- Pregnant women
- Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
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: Aer-O-ScopeScreening Colonoscopy | Device | Aer-O-Scope Colonoscopy |
Primary outcome
Ability to screen the entire length of the colon to the cecum.
Time frame: 30 -60 minutes
1 secondary outcome
Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events
Time frame: 24 hours
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 1 Aug 2017.
- 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 M Santo, MD principal investigator
Tel-Aviv Sourasky 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 Colon Cancer and Rectal Cancer, 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 11 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 1 Aug 2017. 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?
Ability to screen the entire length of the colon to the cecum. (time frame: 30 -60 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 1 Aug 2017.