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OpenTrials
Completed

NCT Number: NCT06776913

Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.

The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Endoscopist pick which one to use based on personal preference and what is available.

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Key information

Conditions

Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Screening Colonoscopy Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Weston

Weston, Florida, 33331, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI greater than 30
  • Screening and surveillance colonoscopy

Exclusion criteria

  • Colon surgery
  • Therapeutic colonoscopy
  • Inflammatory bowel disease
  • Terminated procedure due to stool burden, stenosis, or obstructive mass.
  • Colonoscopy for anemia
  • History of incomplete colonoscopy due to technical difficulties

Treatment and study plan

Colonoscopy

Device

Standard Colonoscopy with photo documentation and the recording of procedure timing.

Primary outcomes

  1. Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type.

    Time frame: During Surgery, up to 10 minutes

    The outcome aims to measure the difficult colonoscope which is defined as either not reaching the cecum, needing more than 10 minutes, or the need to exchange to a different device.

Secondary outcomes

  1. Number of Participants With Successful Advancement of Colonoscope to the Cecum

    Time frame: During Surgery

    Number of Participants with successful advancement of colonoscope to the cecum. Cecal intubation rate (CIR)

  2. Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum

    Time frame: During Surgery

    Number of Participants with successful advancement of colonoscope to the terminal ileum. Terminal ileum intubation rate (TIIR)

  3. Time Taken to Advance the Colonoscope From the Rectum to the Cecum.

    Time frame: During Surgery

    Time taken to advance the colonoscope from the rectum to the cecum. Insertion time (IT)

  4. Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time)

    Time frame: During Surgery

    Time from terminal ileum picture or last cecal picture to rectal picture. Subtract 1 min per each intervention (polypectomy, cauterization...)

  5. Ancillary Maneuvers Used to Facilitate Colonoscope Advancement

    Time frame: During Surgery

    Using ancillary maneuvers during colonoscopy (position change, pressure application, increase stiffness, etc...) to facilitate colonoscope advancement through the colon.

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Florida

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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