NCT05751824

Brief Summary

In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups were compared.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
867

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Feb 2023Dec 2029

First Submitted

Initial submission to the registry

November 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 26, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

5.8 years

First QC Date

November 7, 2022

Last Update Submit

March 7, 2023

Conditions

Artificial IntelligenceSurveillance

Keywords

surveillance rateautomatic surveillance

Outcome Measures

Primary Outcomes (1)

  • surveillance rate

    The numerator is the number of patients with surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.

    From enrollment to study completion, assessed up to 3 years.

Secondary Outcomes (10)

  • Advance Surveillance Rate

    From enrollment to study completion, assessed up to 3 years.

  • On-time Surveillance Rate

    From enrollment to study completion, assessed up to 3 years.

  • Delayed Surveillance Rate

    From enrollment to study completion, assessed up to 3 years.

  • The accuracy of identifing post-polypectomy patients

    At the time of enrollment.

  • The accuracy of classifying risk levels

    At the time of enrollment.

  • +5 more secondary outcomes

Study Arms (3)

With automatic surveillance system

EXPERIMENTAL

Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time.

Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)

With manual reminder

ACTIVE COMPARATOR

Patients were reminded of the surveillance time manually before the surveillance time.

Other: Manually remind the patients to review.

Normal group

NO INTERVENTION

The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.

Interventions

AI based automatic surveillance (AS) system (ENDOANGEL-AS)OTHER

An automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.

With automatic surveillance system
Manually remind the patients to review.OTHER

Medical staff remind patients to review by telephone.

With manual reminder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 years or older who undergo colonoscopy.

You may not qualify if:

  • )No pathological result.
  • \) No or invalid contact information.
  • \) The surveillance interval cannot be determined according to the surveillance guidelines, including poor bowel preparation, colorectal cancer or suspicious malignance, surgery or colorectal ESD history, those who fail to complete colonoscopy due to unbearable, pathological indications of not polyps, hamartoma or lymphoma polyps, history of ulcerative colitis, and so on.
  • \) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
  • \) Have drug or alcohol abuse or psychological disorder in the past five years.
  • ）Pregnancy.
  • ）Not suitable for recruitment after investigator evaluation because of other high-risk conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Honggang Yu, phD

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Honggang Yu, phD

CONTACT

13871281899yuhonggang1969@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

March 2, 2023

Study Start

February 26, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)