Evaluating the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewing Colon Images

September 14, 2023 updated by: Wuhan Union Hospital, China

A Prospective, Multi-center, Randomized and Self-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewing Colon Images Clinically

The trial is a prospective,multi-center, randomized and self-controlled clinical trial. The research plan will be implemented in a clinical trial center with the qualification of clinical trial agency, and 128 subjects will be planned to be included. Subjects signing the Informed Consent Form, meeting the trial conditions and all inclusion criteria and failing to meet any exclusion criteria will be included in the research. The trial device was Colon Capsule Endoscope System for colonoscopy(PC-I) manufactured by ANKON Technologies Co.,Ltd. while the comparator device was Capsule Endoscopy System(PillCam COLON2) manufactured by Given Imaging Inc. The main evaluation indicator is the excellent rate of image quality, while secondary evaluation indicators are the consistency rate of lesion detection, completion rate of colonoscopy, discharge time of capsule endoscopy, colon passing time and device performance evaluation. Safety evaluation indicators include adverse events(or Serious adverse events), device-related adverse events(or Serious adverse events) and device defects. In the end, the effectiveness and safety of Colon Capsule Endoscopy diagnostic system manufactured by ANKON Technologies Co.,Ltd. for capturing and viewing colon images clinically were verified according to the above indicator results.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

According to the relevant requirements of Standard for Quality Management of Medical Device Clinical Trials (Order No. 25 of the National Health and Family Planning Commission of the People's Republic of China of China Food and Drug Administration), the sample size was estimated based on the excellent rate of the image quality of the main endpoint by referring to the domestic and foreign literatures using positive comparator devices. Combined with literatures and comments of clinical experts, the research set the excellent rate of image quality of comparator device Ps as 95%, and estimated the excellent rate of image quality of trial device Pt as 95%. In the research, the non-inferiority trial design was adopted, with α = 0.025 (unilateral), assurance 1 - β = 0.8, and non-inferiority boundary value of -10%, and self-control was adopted. It is assumed that the redundant parameter (that is, the proportion of subjects whose evaluation results of image quality between trial devices and comparator devices are inconsistent) was 0.095 (that is, Pt (1 - Ps) + Ps (1 - Pt)), the total sample size of the two groups was 102 cases calculated by PASS2021, with 51 cases in each swallowing orders I and II. Considering the shedding and rejection rate of 20% during the trial, a total of 128 subjects were needed, with 64 cases in each swallowing orders I and II.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years old (including 18 years old), male or female;
  • Subjects intending to take capsule endoscopy and/or the electronic endoscopy of the lower digestive tract;
  • The subject signed the ICF voluntarily.

Exclusion Criteria:

  • Subjects suffering from swallowing obstruction or deglutition disorders;
  • Subjects who underwent gastrointestinal abdominal surgery in the past 6 month (except for simple surgery unlikely to cause intestinal obstruction according to the clinical judgment of researchers).
  • Subjects of CRC (advanced adenomatous polyp and CRC) failing to undergo the surgery;
  • Subjects suffering from gastrointestinal obstruction, stenosis or fistula;
  • Subjects being unable to take capsule endoscopy due to intestinal preparation failure;
  • Subjects with cardiac pacemakers or other implantable electronic medical devices;
  • Subjects failing to meet requirements for the abdominal surgery or refusing to take any abdominal surgery;
  • Female subjects during pregnancy, lactation or having a pregnancy plan recent 3 months;
  • Subjects who underwent colonoscopy within 2 years, with the negative result;
  • Subjects suffering from type 1 or type 2 diabetes;
  • Subject taking incomplete colonoscopy due to enteropathy of severe ulcerative colitis, radiation enteritis or non-steroidal anti-inflammatory drugs[4];
  • Subjects suffering from any disease considered to increase the retention risk of the capsule endoscopy;
  • Subjects currently participating in another clinical trial of drugs or devices;
  • Other circumstances unsuitable for inclusion upon judgment by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Swallowing order I
First swallow the trial device(PC-I) for examination, and then swallow the comparator device(COLON2) for examination at an interval of 2h.
Device: PC-I and COLON2
First swallow the trial device(PC-I) for examination, and then swallow the comparator device(COLON2) for examination at an interval of 2h.
Experimental: Swallowing order II
First swallow the comparator device(COLON2) for examination, and then swallow the trial device(PC-I) for examination at an interval of 2h.
Device: COLON2 and PC-I
First swallow the comparator device(COLON2) for examination, and then swallow the trial device(PC-I) for examination at an interval of 2h.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The excellent rate of image quality.
Time Frame: 1 day
The main effectiveness evaluation indicator is the excellent rate of image quality, which is for the statistics of the difference between the excellent rate of image quality of trial devices and comparator devices and unilateral 97.5% confidence interval. If the lower limit of unilateral 97.5% confidence interval of the difference between the two groups is greater than -10% of the non-inferiority boundary value, it can be considered that the excellent rate of image quality of trial devices is not inferior to that of comparator devices.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The consistency rate of lesion detection
Time Frame: 1 day
2 associate chief physicians of digestive endoscopy or attending physicians with more than 5 years of endoscopic experience adopted independent film reading in the center for recording of the lesion detection in the image through back-to-back interpretation and analysis. Then record the number of lesions detected consistently.
1 day
Completion rate of colonoscopy
Time Frame: 1-14 days
Colonoscopy is completed before the battery runs out, and the capsule endoscopy captures the rectal segment image or the image that the capsule endoscopy is discharged from the body.
1-14 days
Discharge time of capsule endoscopy
Time Frame: 1-14 days
The discharge time of the capsule endoscopy is from swallowing capsule endoscopy to discharging capsule endoscopy.
1-14 days
Colon passing time
Time Frame: 0.5-10hours
Colon passing time is from the capsule endoscopy's arrival at the ileocecal valve to the capsule endoscopy's discharge from the body.
0.5-10hours
Device performance evaluation
Time Frame: 1day
Subjective evaluation of the performance of the trial and control devices.
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Union Hospital, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Renmin Hospital of Wuhan University
Beijing Tsinghua Changgeng Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: XiaoHua Hou, MD.PhD, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK-CTP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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