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

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: Completed
• Conditions: Prospective Study
• Intervention / Treatment: Device: PC-I and COLON2; Device: COLON2 and PC-I

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: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The excellent rate of image quality.	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

Outcome Measure	Measure Description	Time Frame
The consistency rate of lesion detection	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	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	The discharge time of the capsule endoscopy is from swallowing capsule endoscopy to discharging capsule endoscopy.	1-14 days
Colon passing time	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	Subjective evaluation of the performance of the trial and control devices.	1day

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: Renmin Hospital of Wuhan University; Beijing Tsinghua Changgeng Hospital
• Investigators: Principal Investigator: XiaoHua Hou, MD.PhD, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID 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