Recruiting

C3PO

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04777019

Conditions

Colonic Polyp

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Not applicable as standard of care Colonoscopy

Study Details

Brief summary:

Computer aided detection (CADe) algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy. The aim of this study was to investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls from two different institutes.

Conditions

Colonic Polyp

Study ID

NCT04777019

Start date

Jun 7, 2020

Status verified date

May, 2022

Completion date

Jun 6, 2025

Anticipated

Primary completion date

Jun 7, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients scheduled for a regular or screening colonoscopy at the institution as standard of care.
  • Over 18 years of age

Exclusion Criteria:

  • None if they qualify based on inclusion criteria
  • Pregnant patients
  • Inmate or prisoners
  • Unable to provide informed consent

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Not applicable as standard of care Colonoscopy

Not applicable since not an intervention

Primary outcome measure

  • To investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Prithvi B Patil, MS

7134801179prithvi.b.patil@uth.tmc.edu

Nirav Thosani, MD, MHA

7135006677nirav.thosani@uth.tmc.edu

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Prithvi B Patil

713-480-1179prithvi.b.patil@uth.tmc.edu

Prithvi Patil, MS

7135006456prithvi.b.patil@uth.tmc.edu

Principal Investigator:

Nirav Thosani, MD,MHA

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 18, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2022-05-18.