Back to resultsValidation of Aer-O-Scope Colonoscope System Cecal Intubation
Primary Purpose
Colonic Polyp, Colonic Neoplasms, Colonic Diseases
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Aer-O-Scope Colonoscopy
Sponsored by
About this trial
This is an interventional prevention trial for Colonic Polyp focused on measuring screening-colonoscopy, diagnostic-colonoscopy, surveillance-colonoscopy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Cohort
Arm Description
61 subjects will undergo colonoscopy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03949777
Brief Title
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Official Title
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
November 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI View Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Colonic Neoplasms, Colonic Diseases, Colon Adenoma, Colon Disease, Colon Adenocarcinoma, Colon Cancer
Keywords
screening-colonoscopy, diagnostic-colonoscopy, surveillance-colonoscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Cohort
Arm Type
Experimental
Arm Description
61 subjects will undergo colonoscopy
Intervention Type
Device
Intervention Name(s)
Aer-O-Scope Colonoscopy
Other Intervention Name(s)
therapeutic intervention - polyp resection
Intervention Description
resection or biopsy of colonic abnormalities for histopathalogical evaluation
Primary Outcome Measure Information:
Title
Aer-O-Scope Validation of Cecal Intubation
Description
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Gluck, MD
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual patient data will be shared
Learn more about this trial
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
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