Colonic Adenomatous PolypsNCT02117232
Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon
A study testing Visualization balloon and Traditional CO2 insufflation colonoscopy in people with Colonic Adenomatous Polyps, run by Mercy Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Adenomatous Polyps
- What is being tested?
- Visualization balloon and Traditional CO2 insufflation colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2017
- 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 17 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Colonoscopy With the "Visualization" Balloon
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.
Read the 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.
- 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.
- Complications during and after colonoscopy. 9. Polyp detection rate.
- Conditions
- Colonic Adenomatous Polyps
- Being tested
- Visualization balloon, Traditional CO2 insufflation colonoscopy
- Keywords
- colonoscopy, cecal intubation, carbon dioxide insufflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualization balloonDevice
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.
Traditional CO2 insufflation colonoscopyDevice
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon
| Study group | Role | What they receive |
|---|---|---|
| Visualization balloon | Experimental | Colonoscopy performed with the use of "Visualization" balloon Receives: Device: Visualization balloon |
| Traditional CO2-insufflation colonoscopy | Active comparator | Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon Receives: Device: Traditional CO2 insufflation colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation time
Time required to reach cecum
Measured: Immediately
Secondary outcomes (5)
Length of colonoscope when it reaches cecum
Total length of colonoscope when it reaches cecum
Measured: Immediately
Ease of colonoscope insertion
Easy of colonoscope insertion to cecum
Measured: Immediate
Dose of analgesics and sedatives used
Dose of analgesics and sedatives used during insertion and total dose for the entire procedure
Measured: Immediately
Patient satisfaction
Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.
Measured: Immediately and in 24 hours
Total procedure time
Total time required to complete colonoscopy
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic Adenomatous PolypsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Kantsevoy, Mercy Medical Center
- Investigators
- Sergey V Kantsevoy, MD, PhD, Principal investigator, Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117232
- Sponsor's protocol ID
- VB-001
- Status last verified
- Aug 2018
- First submitted
- 11 Apr 2014
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Colonoscopy With the "Visualization" Balloon
- ClinicalTrials.gov ID
- NCT02117232
- Acronym / sponsor ID
- VB-001
- Conditions
- Colonic Adenomatous Polyps
- Keywords
- colonoscopy, cecal intubation, carbon dioxide insufflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Apr 2014 (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.
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.
- 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.
- Complications during and after colonoscopy. 9. Polyp detection rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visualization balloon | Experimental | Device: Visualization balloonColonoscopy performed with the use of "Visualization" balloon |
| Traditional CO2-insufflation colonoscopy | Active comparator | Device: Traditional CO2 insufflation colonoscopyTraditional colonoscopy performed with CO2 insufflation without "Visualization" balloon |
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Visualization balloonThe "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. | Device | Visualization balloon |
| Traditional CO2 insufflation colonoscopyTraditional colonoscopy performed with CO2 insufflation without "Visualization" balloon | Device | Traditional CO2-insufflation colonoscopy |
Primary outcome
Cecal intubation time
Time frame: Immediately
Time required to reach cecum
5 secondary outcomes
Length of colonoscope when it reaches cecum
Time frame: Immediately
Ease of colonoscope insertion
Time frame: Immediate
Dose of analgesics and sedatives used
Time frame: Immediately
Patient satisfaction
Time frame: Immediately and in 24 hours
Total procedure time
Time frame: Immediately
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 21 Aug 2018.
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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.
Sergey V Kantsevoy, MD, PhD principal investigator
Mercy 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 Visualization balloon and Traditional CO2 insufflation colonoscopy in people with Colonic Adenomatous Polyps, run by Mercy Medical Center at 1 site in United States.
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 6 inclusion and 7 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 21 Aug 2018. 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 United States. 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?
Cecal intubation time (time frame: Immediately). 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 21 Aug 2018; AzTrials last refreshed its copy on 3 Nov 2026.