Back to resultsEffectiveness and Safety of the Colonoscopy With "Visualization" Balloon
Primary Purpose
Colonic Adenomatous Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visualization balloon
Traditional CO2 insufflation colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Adenomatous Polyps focused on measuring colonoscopy, cecal intubation, carbon dioxide insufflation
Eligibility Criteria
Inclusion Criteria:
- The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or for diagnostic workup.
- Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
- Age from 17 to 90 years.
- Be willing and able to comply with the requirements of the protocol.
- Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
- Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.
Exclusion Criteria:
- Subjects with a history of previous colonic resection.
- Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).
- Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
- Subjects with suspected colonic strictures potentially precluding complete colonoscopy.
- Subjects who received any experimental drug or device within the previous three months.
- Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
- Subjects who possessed any psychological condition, or were under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.
Sites / Locations
- Mercy Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visualization balloon
Traditional CO2-insufflation colonoscopy
Arm Description
Colonoscopy performed with the use of "Visualization" balloon
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon
Outcomes
Primary Outcome Measures
Cecal intubation time
Time required to reach cecum
Secondary Outcome Measures
Length of colonoscope when it reaches cecum
Total length of colonoscope when it reaches cecum
Ease of colonoscope insertion
Easy of colonoscope insertion to cecum
Dose of analgesics and sedatives used
Dose of analgesics and sedatives used during insertion and total dose for the entire procedure
Patient satisfaction
Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.
Total procedure time
Total time required to complete colonoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02117232
Brief Title
Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon
Official Title
A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Colonoscopy With the "Visualization" Balloon
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Colonoscopy has become the "gold standard" in detection of colonic polyps and colon cancer. However, colonoscopy causes significant abdominal discomfort and abdominal pain during and after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and pain are mostly caused by air insufflation and intubation difficulties during advancement of the colonoscope in order the reach the cecum.
Study Hypothesis: Use of the "Visualization" Balloon will facilitate advancement of the colonoscope and will eliminate the need for colonic distention with the air or CO2, which can shortened the length of the procedure, reduce patient's discomfort and can decrease amount of sedatives and analgesics used during colonoscopy.
Detailed Description
The goal of this study is to evaluate effectiveness and safety of a "Visualization" Balloon for performance of colonoscopy.
Our hypothesis is that, use of "Visualization" Balloon will decrease colonic distention, patient's discomfort, use of sedatives and analgetics during procedure and will simplify the performance of colonoscopy resulting in shortening of procedure time and increasing the rate of cecal intubation.
Specific aims of the study:
To compare procedure time and effectiveness of the "Visualization" Balloon colonoscopy with traditional CO2-insufflation colonoscopy.
To compare safety profiles between traditional CO2-insufflation colonoscopy and colonoscopy using the "Visualization" Balloon.
4 STUDY ENDPOINTS 4.1 Primary Outcome To compare the mean cecal intubation time achieved with "Visualization" Balloon colonoscopy, with the mean cecal intubation time achieved with standard colonoscopy using CO2 insufflation.
4.2 Secondary Outcomes
To compare "Visualization" Balloon colonoscopy with standard CO2-insufflation colonoscopy in regards of:
Total amount of carbon dioxide (CO2) gas for colonic insufflation used during the procedure.
Ease of colonoscope insertion.
The length of the colonoscope when it reaches the cecum. 4 Colonoscope withdrawal time and total procedure time.
5. Cecal intubation rate. 6. Total dosage of analgesics and sedative during procedure. 7. Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.
8. Complications during and after colonoscopy. 9. Polyp detection rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenomatous Polyps
Keywords
colonoscopy, cecal intubation, carbon dioxide insufflation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visualization balloon
Arm Type
Experimental
Arm Description
Colonoscopy performed with the use of "Visualization" balloon
Arm Title
Traditional CO2-insufflation colonoscopy
Arm Type
Active Comparator
Arm Description
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon
Intervention Type
Device
Intervention Name(s)
Visualization balloon
Intervention Description
The "Visualization" Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the "Visualization" Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The "Visualization" Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The "Visualization" Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon.
Intervention Type
Device
Intervention Name(s)
Traditional CO2 insufflation colonoscopy
Intervention Description
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon
Primary Outcome Measure Information:
Title
Cecal intubation time
Description
Time required to reach cecum
Time Frame
Immediately
Secondary Outcome Measure Information:
Title
Length of colonoscope when it reaches cecum
Description
Total length of colonoscope when it reaches cecum
Time Frame
Immediately
Title
Ease of colonoscope insertion
Description
Easy of colonoscope insertion to cecum
Time Frame
Immediate
Title
Dose of analgesics and sedatives used
Description
Dose of analgesics and sedatives used during insertion and total dose for the entire procedure
Time Frame
Immediately
Title
Patient satisfaction
Description
Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.
Time Frame
Immediately and in 24 hours
Title
Total procedure time
Description
Total time required to complete colonoscopy
Time Frame
Immediately
Other Pre-specified Outcome Measures:
Title
Amount of carbon dioxide used
Description
Total amount of carbon dioxide used during colonoscopy
Time Frame
Immediately
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or for diagnostic workup.
Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
Age from 17 to 90 years.
Be willing and able to comply with the requirements of the protocol.
Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.
Exclusion Criteria:
Subjects with a history of previous colonic resection.
Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).
Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
Subjects with suspected colonic strictures potentially precluding complete colonoscopy.
Subjects who received any experimental drug or device within the previous three months.
Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
Subjects who possessed any psychological condition, or were under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey V Kantsevoy, MD, PhD
Organizational Affiliation
Mercy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon
We'll reach out to this number within 24 hrs