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

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Screening Colonoscopy; Obesity (body Mass Index >30 Kg/m2)

Treatments: Device: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06776913

24-891

Details and patient eligibility

About

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. Doctors pick which one to use based on personal preference and what is available.

Enrollment: 224 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

Adult Colonoscope

Active Comparator group

Description:

Adult colonoscope

Treatment:

Device: Colonoscopy

Pediatric Colonoscope

Active Comparator group

Description:

Pediatric colonoscope

Treatment:

Device: Colonoscopy