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

NCT05308511 | Completed

• 1 other identifier: AK-CTP-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prospective Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The consistency rate of lesion detection

  1 day

• Completion rate of colonoscopy

  1-14 days

• Discharge time of capsule endoscopy

  1-14 days

• Colon passing time

  0.5-10hours

• Device performance evaluation

  1day

Study Arms (2)

Swallowing order I

EXPERIMENTAL

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

Swallowing order II

EXPERIMENTAL

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

Interventions

PC-I and COLON2 DEVICE

First swallow the trial device(PC-I) for examination, and then swallow the comparator device(COLON2) for examination at an interval of 2h.

Swallowing order I

COLON2 and PC-I DEVICE

First swallow the comparator device(COLON2) for examination, and then swallow the trial device(PC-I) for examination at an interval of 2h.

Swallowing order II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Renmin Hospital of Wuhan University: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator

Study Sites (1)

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Study Officials

• XiaoHua Hou, MD.PhD

  Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is a prospective, multi-center,randomized, self-controlled,and non-inferiority design clinical trial. Subjects included in the research were subject to capsule endoscopy in one swallowing order (two in total), which was determined by the pre-generated random number. 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. 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.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 4, 2022
• Study Start: April 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: August 4, 2023
• Last Updated: September 18, 2023

Record last verified: 2022-04

Locations

CN (1)