Intestinal PolypsNCT05481632
Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
A study testing Endoangel assisted the process of colonoscopy and Colonoscopy was performed without endoangel assistance in people with Intestinal Polyps, run by Ruijin Hospital at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Polyps
- What is being tested?
- Endoangel assisted the process of colonoscopy and Colonoscopy was performed without endoangel assistance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,360 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2021to 4 Mar 2022
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 75 years old, male or female;
- Subjects with colonoscopy diagnosis and screening needs;
- Sign the Written Informed Consent Form;
- With full capacity for civil conduct.
Who cannot join
- History of acute myocardial infarction (within 6 months), severe heart, liver, and renal insufficiency or mental disease;
- Patients who are taking aspirin, warfarin, and other anticoagulants;
- Patients with inflammatory bowel disease, or polyposis syndromes, or confirmed or highly suspected colon cancer;
- History of colorectal surgery;
- Patients with familial adenomatous polyposis;
- Pregnant women (if the subject is a woman of reproductive age and cannot confirm whether she is pregnant, a pregnancy test is required);
- Patients who are participating in clinical trials of other drugs or medical devices;
- Patients who are not eligible to participate in this clinical trial in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
About this study
To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd.
- Conditions
- Intestinal Polyps
- Being tested
- Endoangel assisted the process of colonoscopy, Colonoscopy was performed without endoangel assistance
- Medical subject headings
- Intestinal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoangel assisted the process of colonoscopyOther
Endoangel assisted doctors to detect polyps
Colonoscopy was performed without endoangel assistanceOther
Polyps were detected without ENDOANGEL assistance
| Study group | Role | What they receive |
|---|---|---|
| Physician AI-assisted diagnosis group | Experimental | Not described Receives: Other: Endoangel assisted the process of colonoscopy |
| Physician Independent Diagnostic Group | Sham comparator | Not described Receives: Other: Colonoscopy was performed without endoangel assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of polyps identification
The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
Measured: 3 months
specificity of polyps identification
The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.
Measured: 3 months
Secondary outcomes (1)
Polyp detection rate
The numerator is subjects with polyps detected and the denominator is all subjects.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start17 Jan 2021
- Primary completion16 Jul 2021
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal PolypsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Wuhan Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481632
- Sponsor's protocol ID
- EndoAngel -CTP-01
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
- ClinicalTrials.gov ID
- NCT05481632
- Acronym / sponsor ID
- EndoAngel -CTP-01
- Conditions
- Intestinal Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Wuhan Central Hospital
- Study start
- 17 Jan 2021 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 1 Aug 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.
To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician AI-assisted diagnosis group | Experimental | Other: Endoangel assisted the process of colonoscopy |
| Physician Independent Diagnostic Group | Sham comparator | Other: Colonoscopy was performed without endoangel assistance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old ≤ age ≤ 75 years old, male or female;
- Subjects with colonoscopy diagnosis and screening needs;
- Sign the Written Informed Consent Form;
- With full capacity for civil conduct.
Key exclusion criteria (8 listed)
- History of acute myocardial infarction (within 6 months), severe heart, liver, and renal insufficiency or mental disease;
- Patients who are taking aspirin, warfarin, and other anticoagulants;
- Patients with inflammatory bowel disease, or polyposis syndromes, or confirmed or highly suspected colon cancer;
- History of colorectal surgery;
- Patients with familial adenomatous polyposis;
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 |
|---|---|---|
| Endoangel assisted the process of colonoscopyEndoangel assisted doctors to detect polyps | Other | Physician AI-assisted diagnosis group |
| Colonoscopy was performed without endoangel assistancePolyps were detected without ENDOANGEL assistance | Other | Physician Independent Diagnostic Group |
Primary outcome
sensitivity of polyps identification
Time frame: 3 months
The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
specificity of polyps identification
Time frame: 3 months
The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.
1 secondary outcome
Polyp detection rate
Time frame: 3 months
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 1 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoangel assisted the process of colonoscopy and Colonoscopy was performed without endoangel assistance in people with Intestinal Polyps, run by Ruijin Hospital 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 4 inclusion and 8 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 1 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
sensitivity of polyps identification (time frame: 3 months). The study lists 2 primary outcomes in all. 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 1 Aug 2022.