ClinicalTrials.gg
Not yet recruitingNCT07245173Updated Nov 24, 2025

Randomized Control Trial Comparing the Incidence of Loop Formation in Colonoscopy Techniques

An interventional study of colonoscopy in Colon Cancer Screening, sponsored by Memorial University of Newfoundland. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Memorial University of Newfoundland · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Colon Cancer Screening

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03

In context

Colonic Neoplasms

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's planned enrollment of 142 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Memorial University of Newfoundland is the lead sponsor of 49 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Consenting patients who are undergoing a routine colonoscopy.
  • Ages between 18-80 years old.

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
  • Inability to provide .
  • History of prior colonic surgery.
  • Poor bowel preparation.
  • Known bowel obstruction.
  • Emergency colonoscopy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
142 participants (estimated)

Study arms

  • Experimental
    Colonoscopy with water insufflation

    Colonoscopy performed using just water to inflate the colon

    Diagnostic Test: colonoscopy

  • Experimental
    Colonoscopy with air insufflation

    Colonoscopy performed using just air to inflate the colon

    Diagnostic Test: colonoscopy

Interventions

  • Diagnostic testcolonoscopy

    Colonoscopy performed using just water or just air to inflate the colon

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07245173
Lead sponsor
Memorial University of Newfoundland
Responsible party
David Pace (Dr. Davis Pace, Memorial University of Newfoundland) — Principal investigator
First posted
Nov 24, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 24, 2025

Study contacts

Dave Pace, MD
Contact
dpace@mun.ca
17096852813

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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