Prospective StudyNCT05308511
Evaluating the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewing Colon Images
A study testing PC-I and COLON2 and COLON2 and PC-I in people with Prospective Study, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prospective Study
- What is being tested?
- PC-I and COLON2 and COLON2 and PC-I
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 4 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: 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.
Read the 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.
- Conditions
- Prospective Study
- Being tested
- PC-I and COLON2, COLON2 and PC-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-I and COLON2Device
First swallow the trial device(PC-I) for examination, and then swallow the comparator device(COLON2) for examination at an interval of 2h.
COLON2 and PC-IDevice
First swallow the comparator device(COLON2) for examination, and then swallow the trial device(PC-I) for examination at an interval of 2h.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: COLON2 and PC-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 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.
Measured: 1-14 days
Discharge time of capsule endoscopy
The discharge time of the capsule endoscopy is from swallowing capsule endoscopy to discharging capsule endoscopy.
Measured: 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.
Measured: 0.5-10hours
Device performance evaluation
Subjective evaluation of the performance of the trial and control devices.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2022
- Primary completion31 May 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective StudyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Beijing Tsinghua Changgeng Hospital
- Responsible party
- Sponsor
- Investigators
- XiaoHua Hou, MD.PhD, Principal investigator, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308511
- Sponsor's protocol ID
- AK-CTP-01
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05308511
- Acronym / sponsor ID
- AK-CTP-01
- Conditions
- Prospective Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Beijing Tsinghua Changgeng Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Swallowing order I | Experimental | Device: PC-I and COLON2First 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 | Experimental | Device: COLON2 and PC-IFirst swallow the comparator device(COLON2) for examination, and then swallow the trial device(PC-I) for examination at an interval of 2h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-I and COLON2First swallow the trial device(PC-I) for examination, and then swallow the comparator device(COLON2) for examination at an interval of 2h. | Device | Swallowing order I |
| COLON2 and PC-IFirst swallow the comparator device(COLON2) for examination, and then swallow the trial device(PC-I) for examination at an interval of 2h. | Device | Swallowing order II |
Primary outcome
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.
5 secondary outcomes
The consistency rate of lesion detection
Time frame: 1 day
Completion rate of colonoscopy
Time frame: 1-14 days
Discharge time of capsule endoscopy
Time frame: 1-14 days
Colon passing time
Time frame: 0.5-10hours
Device performance evaluation
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoHua Hou, MD.PhD principal investigator
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC-I and COLON2 and COLON2 and PC-I in people with Prospective Study, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The excellent rate of image quality. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.