Colonoscopy, ColorectalNCT02739893
Usefulness of A Scope Guide Assisted Colonoscopy Versus Conventional Colonoscopy
A study testing Scope Guide Assist and Standard procedure for colonoscopy in people with Colonoscopy, Colorectal, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The aim of this study is to see if use of ScopeGuide, as compared to the traditional colonoscope, improves successful completion of colonoscopy procedures as evaluated by ease of completion, time to completion, and reduction in the number of mechanical loops and external maneuvers required to advance the scope. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Colorectal
- What is being tested?
- Scope Guide Assist and Standard procedure for colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 7 Feb 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to safely undergo colonoscopy without history of colorectal surgery, colonic stricture or obstruction.
Who cannot join
- history of colorectal surgery,
- current colonic stricture or obstruction,
- unable to safely undergo colonoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing the Usefulness of A Scope Guide Assisted Colonoscopy Versus Conventional Colonoscopy
The aim of this study is to see if use of ScopeGuide, as compared to the traditional colonoscope, improves successful completion of colonoscopy procedures as evaluated by ease of completion, time to completion, and reduction in the number of mechanical loops and external maneuvers required to advance the scope. Other outcome measures include looking at the amount of sedation required (independent of weight) and polyp rate detection.
Read the detailed description
Currently, the standard practice consists of utilizing a traditional colonoscope and depends on manual manipulation and learned expertise of human anatomy. If the scope guide reduces the amount of external maneuvers required, this will reduce patient discomfort and may reduce sedative requirements during procedure. Reduction in mechanical loops formed while advancing the scope will reduce the amount of time per procedure and potentially increase polyp detection. Additionally, if the physician is unable to complete the procedure (as indicated by reaching the cecum (anatomical structure signifying the end of the colon), clinical data may be lost. A reduction in the number of loops formed and ease of advancing scope will facilitate completion of procedure.
The patient will not be exposed to any inconvenience, danger, or discomfort as a result of study participation. Patients undergoing colonoscopy as SOC, if enrolled into the study, will be randomized by envelope at the time of procedure. If the patient is randomized to the scope guide, the PI simply activates the guide through a mechanical button placed on the scope itself. If the patient is randomized to SOC, the physician proceeds with the colonoscopy without activating the scope guide. The same scope is used regardless of randomization result. The physician is able to turn on and off the magnetic function through the touch of a button.
The colonoscopy procedure itself is not dependent upon use of the scope guide. However, the use of the scope guide may assist the physician in performing the procedure with less physical manipulation. Without the use of the ScopeGuide, an endoscopist is able to perform the procedure based off anatomical knowledge and through the use of maneuvers such as changing the patient position and applying external pressure. This study will test if the ScopeGuide decreases the number of maneuvers required for completion. If the number of maneuvers is decreased, it is likely to decrease patient discomfort and decrease the duration of procedure. This study will also test of the ScopeGuide increases completeness of procedure.
300 patients undergoing SOC colonoscopy will be randomized 1:1 to receive traditional colonoscopy or scope guide assisted colonoscopy.
This study will assess if the scope guide assist function improves successful completion of colonoscopy, time to completion, and reduction in the number of mechanical loops and external maneuvers required to advance the scope. Polyp detection rate and amount of sedation required will also be assessed.
- Conditions
- Colonoscopy, Colorectal
- Being tested
- Scope Guide Assist, Standard procedure for colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scope Guide AssistProcedure or surgery
Olympus has developed a new instrument which provides physicians a real-time, three dimensional visualization of position and configuration during colonoscopy. The Olympus ScopeGuide technology has received FDA clearance and can be used within the United States. The new technology called the 'scopeguide' has been developed that uses magnetic coils embedded into the scope to create a 3 D image of the shape of the entire scope inside the body that is projected onto the monitor to see. This acts as a "GPS" and shows the advancement of the scope through bends providing information on loops and thereby eliminating chances of loop formation, helping in loop reduction and also reducing the number of external maneuvers that may be required for the completion of colonoscopy.
Standard procedure for colonoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Scope Guide Assisted | Experimental | Scope Guide Assist to be utilized during colonoscopy Receives: Procedure: Scope Guide Assist |
| Standard | Placebo comparator | Colonoscopy completed using current SOC without scopeguide assist. Receives: Procedure: Standard procedure for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cecum intubation time for each arm
time in minutes to reach cecum destination in each arm
Measured: from start of colonoscopy until completion - approximately 60 minutes
Mean time in minutes to complete colonoscopy
Mean time to completion for each arm
Measured: from start of colonoscopy until completion - approximately 60 minutes
Mean number of mechanical loops required to complete procedure for each arm
Each mechanical loop will be counted as 1 (one)
Measured: from start of colonoscopy until completion - approximately 60 minutes
Number of mean external maneuvers per procedure between groups
mean number of external maneuvers across all subjects in each arm
Measured: from start of colonoscopy until completion - approximately 60 minutes
Secondary outcomes (2)
Mean amount of sedation per arm
amount of sedation in mg per arm
Measured: from start of colonoscopy until completion - approximately 60 minutes
Percent of subjects with detectable polyps per arm
percent of subjects in each with at least identifiable polyp
Measured: from start of colonoscopy until completion - approximately 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJan 2016
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy, ColorectalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shajan P. Sugandha, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739893
- Sponsor's protocol ID
- F141223002
- Status last verified
- Feb 2019
- First submitted
- 25 Mar 2016
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing the Usefulness of A Scope Guide Assisted Colonoscopy Versus Conventional Colonoscopy
- ClinicalTrials.gov ID
- NCT02739893
- Acronym / sponsor ID
- F141223002
- Conditions
- Colonoscopy, Colorectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 15 Apr 2016 (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.
The aim of this study is to see if use of ScopeGuide, as compared to the traditional colonoscope, improves successful completion of colonoscopy procedures as evaluated by ease of completion, time to completion, and reduction in the number of mechanical loops and external maneuvers required to advance the scope. Other outcome measures include looking at the amount of sedation required (independent of weight) and polyp rate detection.
Detailed description
Currently, the standard practice consists of utilizing a traditional colonoscope and depends on manual manipulation and learned expertise of human anatomy. If the scope guide reduces the amount of external maneuvers required, this will reduce patient discomfort and may reduce sedative requirements during procedure. Reduction in mechanical loops formed while advancing the scope will reduce the amount of time per procedure and potentially increase polyp detection. Additionally, if the physician is unable to complete the procedure (as indicated by reaching the cecum (anatomical structure signifying the end of the colon), clinical data may be lost. A reduction in the number of loops formed and ease of advancing scope will facilitate completion of procedure.
The patient will not be exposed to any inconvenience, danger, or discomfort as a result of study participation. Patients undergoing colonoscopy as SOC, if enrolled into the study, will be randomized by envelope at the time of procedure. If the patient is randomized to the scope guide, the PI simply activates the guide through a mechanical button placed on the scope itself. If the patient is randomized to SOC, the physician proceeds with the colonoscopy without activating the scope guide. The same scope is used regardless of randomization result. The physician is able to turn on and off the magnetic function through the touch of a button.
The colonoscopy procedure itself is not dependent upon use of the scope guide. However, the use of the scope guide may assist the physician in performing the procedure with less physical manipulation. Without the use of the ScopeGuide, an endoscopist is able to perform the procedure based off anatomical knowledge and through the use of maneuvers such as changing the patient position and applying external pressure. This study will test if the ScopeGuide decreases the number of maneuvers required for completion. If the number of maneuvers is decreased, it is likely to decrease patient discomfort and decrease the duration of procedure. This study will also test of the ScopeGuide increases completeness of procedure.
300 patients undergoing SOC colonoscopy will be randomized 1:1 to receive traditional colonoscopy or scope guide assisted colonoscopy.
This study will assess if the scope guide assist function improves successful completion of colonoscopy, time to completion, and reduction in the number of mechanical loops and external maneuvers required to advance the scope. Polyp detection rate and amount of sedation required will also be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scope Guide Assisted | Experimental | Procedure: Scope Guide AssistScope Guide Assist to be utilized during colonoscopy |
| Standard | Placebo comparator | Procedure: Standard procedure for colonoscopyColonoscopy completed using current SOC without scopeguide assist. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- able to safely undergo colonoscopy without history of colorectal surgery, colonic stricture or obstruction.
Key exclusion criteria (3 listed)
- history of colorectal surgery,
- current colonic stricture or obstruction,
- unable to safely undergo colonoscopy.
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 |
|---|---|---|
| Scope Guide AssistOlympus has developed a new instrument which provides physicians a real-time, three dimensional visualization of position and configuration during colonoscopy. The Olympus ScopeGuide technology has received FDA clearance and can be used within the United States. The new technology called the 'scopeguide' has been developed that uses magnetic coils embedded into the scope to create a 3 D image of the shape of the entire scope inside the body that is projected onto the monitor to see. This acts as a "GPS" and shows the advancement of the scope through bends providing information on loops and thereby eliminating chances of loop formation, helping in loop reduction and also reducing the number of external maneuvers that may be required for the completion of colonoscopy. | Procedure or surgery | Scope Guide Assisted |
| Standard procedure for colonoscopy | Procedure or surgery | Standard |
Primary outcome
Mean cecum intubation time for each arm
Time frame: from start of colonoscopy until completion - approximately 60 minutes
time in minutes to reach cecum destination in each arm
Mean time in minutes to complete colonoscopy
Time frame: from start of colonoscopy until completion - approximately 60 minutes
Mean time to completion for each arm
Mean number of mechanical loops required to complete procedure for each arm
Time frame: from start of colonoscopy until completion - approximately 60 minutes
Each mechanical loop will be counted as 1 (one)
Number of mean external maneuvers per procedure between groups
Time frame: from start of colonoscopy until completion - approximately 60 minutes
mean number of external maneuvers across all subjects in each arm
2 secondary outcomes
Mean amount of sedation per arm
Time frame: from start of colonoscopy until completion - approximately 60 minutes
Percent of subjects with detectable polyps per arm
Time frame: from start of colonoscopy until completion - approximately 60 minutes
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 20 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scope Guide Assist and Standard procedure for colonoscopy in people with Colonoscopy, Colorectal, run by University of Alabama at Birmingham 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 1 inclusion and 3 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 20 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Mean cecum intubation time for each arm (time frame: from start of colonoscopy until completion - approximately 60 minutes). The study lists 4 primary outcomes in all. 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 20 Feb 2019.