Effectiveness of Using the Speedometer During Colonoscopy

Colonic Polyp Clinical Trial

Official title:

Effectiveness of Using the Speedometer During Colonoscopy: a Prospective, Comparative Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04710251
• Other study ID #: 2020P001156
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: Norwegian Department of Health and Social Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PURPOSE OF PROTOCOL Objective: To evaluate if the speedometer based on the real-time image analysis can help endoscopists increase their withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, during colonoscopy. Hypothesis: The trial hypothesis is that use of the speedometer during colonoscopy will increase the average withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, by 1.6 minutes, possibly increasing the performance of the participating endoscopists. Our objective is to clarify the clinical benefits of this digital tool in colonoscopy. Endpoint: Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 332
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Both women and men aged 18 years or older undergoing colonoscopy for any indication at Beth Israel Deaconess Medical Center (BIDMC), Boston, USA.

Exclusion Criteria:

• Known colorectal cancer, hereditary colorectal polyposis, inflammatory bowel disease, or past history of colectomy.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• Speedometer
We will measure and monitor the withdrawal time of colonoscopy with a speedometer.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian Department of Health and Social Affairs	Beth Israel Deaconess Medical Center, Oslo University Hospital, Showa University, University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal time	Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).	Through study completion, an average of 1 year
Secondary	Adenoma detection rate (ADR)	Adenoma detection rate (ADR) of the participating endoscopists during the control period and the intervention period.	Through study completion, an average of 1 year
Secondary	Quality of colonoscopy	Proportion of colonoscopies with withdrawal time = 6 minutes.	Through study completion, an average of 1 year