Colon Cancer ScreeningNCT07245173
Randomized Control Trial Comparing the Incidence of Loop Formation in Colonoscopy Techniques
A study testing colonoscopy in people with Colon Cancer Screening, run by Memorial University of Newfoundland.
Trial summary
A colonoscopy is a common procedure used to check for problems in the colon, such as disease or other health issues. Although it's widely used, one challenge is that the flexible tube used in the procedure (called a colonoscope) can sometimes form loops inside the colon. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer Screening
- What is being tested?
- colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting patients who are undergoing a routine colonoscopy.
- Ages between 18-80 years old.
Who cannot join
- Refusal to participate
- Inability to provide informed consent.
- History of prior colonic surgery.
- Poor bowel preparation.
- Known bowel obstruction.
- Emergency colonoscopy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Control Trial Comparing the Incidence of Loop Formation in Water Infusion Versus Air Insufflation Colonoscopy Techniques
A colonoscopy is a common procedure used to check for problems in the colon, such as disease or other health issues. Although it's widely used, one challenge is that the flexible tube used in the procedure (called a colonoscope) can sometimes form loops inside the colon. When this happens, pushing the tube further doesn't help it move forward-it just makes the loop bigger, which can make the procedure harder to complete. These loops can also cause more pain for the patient, require more sedation (medication to relax or put the patient to sleep), and increase the time it takes to finish the procedure. Because of this, it's important to find ways to reduce loop formation. Two common methods used in colonoscopies are called air insufflation and water infusion.
This study will compare the two methods-air vs. water-to see which one causes fewer loops. It will be a randomized controlled trial, meaning participants will be randomly assigned to one of the two methods. The study will involve real patients, and the data will be collected by physicians, residents (doctors in training), and medical students. During the colonoscopies, images from a tool that guides the scope will be recorded on video.
Read more
Experienced staff doctors and surgical residents (with at least two months of special training in this procedure) will perform the colonoscopies. Each procedure will be supervised by a team member, such as a medical student, resident, or staff doctor. Afterward, two reviewers who don't know which method was used will watch the videos to look for any loops. They will look for specific types of loops, including n, alpha, reverse alpha, reverse splenic, and gamma loops.
The study will also track how long it takes to reach the end of the colon (called the cecum), how comfortable the patient was (using a standard rating system already used in all colonoscopies), and how much sedation was needed.
- Conditions
- Colon Cancer Screening
- Being tested
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyDiagnostic test
Colonoscopy performed using just water or just air to inflate the colon
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy with water insufflation | Experimental | Colonoscopy performed using just water to inflate the colon Receives: Diagnostic Test: colonoscopy |
| Colonoscopy with air insufflation | Experimental | Colonoscopy performed using just air to inflate the colon Receives: Diagnostic Test: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of colonscopy loops formed
The number and type of different colonoscopy loops formed during each colonoscopy will be recorded from the initial insertion of the colonoscope to complete removal of the colonoscope of each colonoscopy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer ScreeningStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Pace, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245173
- Sponsor's protocol ID
- 41436
- Status last verified
- Nov 2025
- First submitted
- 9 Jun 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing the Incidence of Loop Formation in Water Infusion Versus Air Insufflation Colonoscopy Techniques
- ClinicalTrials.gov ID
- NCT07245173
- Acronym / sponsor ID
- 41436
- Conditions
- Colon Cancer Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- 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.
A colonoscopy is a common procedure used to check for problems in the colon, such as disease or other health issues. Although it's widely used, one challenge is that the flexible tube used in the procedure (called a colonoscope) can sometimes form loops inside the colon. When this happens, pushing the tube further doesn't help it move forward-it just makes the loop bigger, which can make the procedure harder to complete. These loops can also cause more pain for the patient, require more sedation (medication to relax or put the patient to sleep), and increase the time it takes to finish the procedure. Because of this, it's important to find ways to reduce loop formation. Two common methods used in colonoscopies are called air insufflation and water infusion.
This study will compare the two methods-air vs. water-to see which one causes fewer loops. It will be a randomized controlled trial, meaning participants will be randomly assigned to one of the two methods. The study will involve real patients, and the data will be collected by physicians, residents (doctors in training), and medical students. During the colonoscopies, images from a tool that guides the scope will be recorded on video.
Experienced staff doctors and surgical residents (with at least two months of special training in this procedure) will perform the colonoscopies. Each procedure will be supervised by a team member, such as a medical student, resident, or staff doctor. Afterward, two reviewers who don't know which method was used will watch the videos to look for any loops. They will look for specific types of loops, including n, alpha, reverse alpha, reverse splenic, and gamma loops.
The study will also track how long it takes to reach the end of the colon (called the cecum), how comfortable the patient was (using a standard rating system already used in all colonoscopies), and how much sedation was needed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with water insufflation | Experimental | Diagnostic Test: colonoscopyColonoscopy performed using just water to inflate the colon |
| Colonoscopy with air insufflation | Experimental | Diagnostic Test: colonoscopyColonoscopy performed using just air to inflate the colon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consenting patients who are undergoing a routine colonoscopy.
- Ages between 18-80 years old.
Key exclusion criteria (6 listed)
- Refusal to participate
- Inability to provide informed consent.
- History of prior colonic surgery.
- Poor bowel preparation.
- Known bowel obstruction.
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 |
|---|---|---|
| colonoscopyColonoscopy performed using just water or just air to inflate the colon | Diagnostic test | Colonoscopy with air insufflation, Colonoscopy with water insufflation |
Primary outcome
Number and type of colonscopy loops formed
Time frame: 12 months
The number and type of different colonoscopy loops formed during each colonoscopy will be recorded from the initial insertion of the colonoscope to complete removal of the colonoscope of each colonoscopy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy in people with Colon Cancer Screening, run by Memorial University of Newfoundland.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dave Pace, MD (17096852813, dpace@mun.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and type of colonscopy loops formed (time frame: 12 months). 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 24 Nov 2025.