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

NCT ID: NCT06776913

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2025-09-24

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Adult Colonoscope

Adult colonoscope

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type DEVICE

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

Pediatric Colonoscope

Pediatric colonoscope

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type DEVICE

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

Interventions

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Colonoscopy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cleveland Clinic Florida

OTHER

Sponsor Role lead

Responsible Party

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Asad Ur Rahman, Fnu

Medical Director, Inflammatory Bowel Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic Weston

Weston, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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24-891

Identifier Type: -

Identifier Source: org_study_id

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