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Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients

Primary Purpose

Colon Cancer, Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Aer-O-Scope Colonoscopy
Sponsored by
GI View Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring polyp

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

  • Sourasky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aer-O-Scope Colonoscopy

Arm Description

Screening Colonoscopy

Outcomes

Primary Outcome Measures

Ability to screen the entire length of the colon to the cecum.

Secondary Outcome Measures

Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events

Full Information

First Posted
March 23, 2009
Last Updated
July 30, 2017
Sponsor
GI View Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00867724
Brief Title
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
Official Title
A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI View Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer
Keywords
polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aer-O-Scope Colonoscopy
Arm Type
Experimental
Arm Description
Screening Colonoscopy
Intervention Type
Device
Intervention Name(s)
Aer-O-Scope Colonoscopy
Other Intervention Name(s)
Aer-O-Scope
Intervention Description
Screening Colonoscopy
Primary Outcome Measure Information:
Title
Ability to screen the entire length of the colon to the cecum.
Time Frame
30 -60 minutes
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwin M Santo, MD
Organizational Affiliation
Tel-Aviv Sourasky 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

Learn more about this trial

Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients

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