Adenoma ColonNCT04654247
Endoscopic Quality Improvement System Study
A study testing Quality audit and feedback in people with Adenoma Colon and Gastric Precancerous Condition, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenoma Colon, Gastric Precancerous Condition
- What is being tested?
- Quality audit and feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2019to 25 Nov 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Endoscopist:
- Endoscopist with more than one year experience in gastrointestinal mirror operation;
- Willing to further improve endoscopic quality through Endo.Adm feedback;
- Ability to read, understand and sign informed consent; The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all research procedures and follow-up visits in conjunction with the research process.
Who cannot join
- Endoscopist:
- Have participated in other clinical trials;
- Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations;
- Endoscopist who were either not present for both parts (phase1 and phase2) of the study.
- Patients:
- Colonoscopy:
Show all 13Show fewer
- Polyposis syndromes
- Lumen obstruction
- History of colorectal surgery
- History of colorectal surgery
- Gastroscopy:
- Obstruction
- History of gastric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy
We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a practical basis for improving the quality of digestive endoscopy in our endoscopic center.
- Conditions
- Adenoma Colon, Gastric Precancerous Condition
- Being tested
- Quality audit and feedback, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality audit and feedbackBehavioural
Endoscopists received quality report generated by Endo.Adm.
ControlBehavioural
None feedback.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Endoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent. Receives: Behavioral: Control |
| Feedback group | Experimental | Endoscopists in feedback group were informed standard quality indicators requirements and the corresponding references during informed consent. In addition to the quality requirements, endoscopists randomized to feedback group received customized quality reports feedback from Endo.Adm weekly. Receives: Behavioral: Quality audit and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Measured: 3 Months
Gastric precancerous detection rate
GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.
Measured: 3 Months
Secondary outcomes (1)
Adcanced ADR
Adcanced ADR was calculated by dividing the total number of patients being detected ≥10mm in size, or adenomas with histopathology of tubulovillous, villous, adenocarcinoma, or high-grade dysplasia by the number of colonoscopies.
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 posted4 Dec 2020
- Study start20 Apr 2019
- Primary completion20 Aug 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma ColonStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654247
- Sponsor's protocol ID
- EA-19-004
- Status last verified
- Nov 2020
- First submitted
- 27 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual de-identified participant data that underlie the results reported in this article and study protocol will be shared for investigators whose proposed use of the data has been approved by an independent review committee. Data can only be used to achieve aims in the approved proposal. Data disclosure begins 9 months and ends 36 months after article publication. To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT04654247
- Acronym / sponsor ID
- EA-19-004
- Conditions
- Adenoma Colon, Gastric Precancerous Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 4 Dec 2020 (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.
We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a practical basis for improving the quality of digestive endoscopy in our endoscopic center.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Behavioral: ControlEndoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent. |
| Feedback group | Experimental | Behavioral: Quality audit and feedbackEndoscopists in feedback group were informed standard quality indicators requirements and the corresponding references during informed consent. In addition to the quality requirements, endoscopists randomized to feedback group received customized quality reports feedback from Endo.Adm weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Endoscopist with more than one year experience in gastrointestinal mirror operation;
- Willing to further improve endoscopic quality through Endo.Adm feedback;
- Ability to read, understand and sign informed consent; The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all research procedures and follow-up visits in conjunction with the research process.
Key exclusion criteria (13 listed)
- Have participated in other clinical trials;
- Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations;
- Endoscopist who were either not present for both parts (phase1 and phase2) of the study.
- Polyposis syndromes
- Lumen obstruction
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 |
|---|---|---|
| Quality audit and feedbackEndoscopists received quality report generated by Endo.Adm. | Behavioural | Feedback group |
| ControlNone feedback. | Behavioural | Control group |
Primary outcome
Adenoma detection rate
Time frame: 3 Months
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Gastric precancerous detection rate
Time frame: 3 Months
GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.
1 secondary outcome
Adcanced ADR
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 4 Dec 2020.
- Individual participant dataSharing planned: Undecided. Individual de-identified participant data that underlie the results reported in this article and study protocol will be shared for investigators whose proposed use of the data has been approved by an independent review committee. Data can only be used to achieve aims in the approved proposal. Data disclosure begins 9 months and ends 36 months after article publication. To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.
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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 Quality audit and feedback in people with Adenoma Colon and Gastric Precancerous Condition, run by Renmin Hospital of Wuhan University 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 13 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 4 Dec 2020. 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?
Adenoma detection rate (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 4 Dec 2020.