NCT06776913

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 20, 2026

Completed
Last Updated

March 20, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

January 10, 2025

Results QC Date

February 2, 2026

Last Update Submit

February 28, 2026

Conditions

Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2)Screening Colonoscopy

Keywords

obesityScreening Colonoscopy

Outcome Measures

Primary Outcomes (1)

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

    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.

    During Surgery, up to 10 minutes

Secondary Outcomes (5)

  • Number of Participants With Successful Advancement of Colonoscope to the Cecum

    During Surgery

  • Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum

    During Surgery

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

    During Surgery

  • Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time)

    During Surgery

  • Ancillary Maneuvers Used to Facilitate Colonoscope Advancement

    During Surgery

Study Arms (2)

Adult Colonoscope

ACTIVE COMPARATOR

Standard colonoscopy performed with adult colonoscope.

Device: Colonoscopy

Pediatric Colonoscope

ACTIVE COMPARATOR

Standard colonoscopy performed with pediatric colonoscope.

Device: Colonoscopy

Interventions

ColonoscopyDEVICE

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

Adult ColonoscopePediatric Colonoscope

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BMI greater than 30
  • Screening and surveillance colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Weston

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Results Point of Contact

Title
Dr. Asad Ur Rahman/ Principal Investigator
Organization
Cleveland Clinic Florida (Weston Hospital)
rahmanf3@ccf.org
9546595000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Inflammatory Bowel Disease Center

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

January 6, 2025

Primary Completion

September 24, 2025

Study Completion

September 24, 2025

Last Updated

March 20, 2026

Results First Posted

March 20, 2026

Record last verified: 2026-02

Locations

US(1)