Colon AdenomaNCT05448300
Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System
A study testing Colonoscopy with water exchange or air insufflation methods in people with Colon Adenoma and Colonoscopy, run by Dalin Tzu Chi General Hospital at 2 sites in 2 countries.
Trial summary
Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Adenoma, Colonoscopy
- What is being tested?
- Colonoscopy with water exchange or air insufflation methods
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 May 2022to 15 May 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive patients, undergoing screen, diagnostic or surveillance colonoscopy performed by the participating endoscopists will be enrolled.
Who cannot join
- We excluded patients age < 50 or > 80 years old, undergone colonoscopy in the past 3 years, partial intake of bowel preparation, renal failure, previous colonic resection, scheduled for polypectomy, American Society of Anesthesiology (ASA) Risk Class 3 or higher, and lack of written informed consent.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
- Active, not recruiting
Sepulveda Ambulatory Care Center
Los Angeles, California, 91343
Taiwan1 site, 1 recruiting
- Recruiting
Chia Pei Tang
Chiayi City, Chiayi County, 62247
Chia P Tang, MD, 0921128335, franktg@hotmail.com
About this study
Official title: Adenoma Detection Using Real-Time Computer-Aided Colon Polyp Detection System to Compare Water Exchange and Air Insufflation - A Randomized Controlled Trial
Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. A modified Delphi review reported water exchange showed the highest overall ADR, ADR in screening cases, and in the right side of the colon compared with water immersion and air (or CO2) insufflation. One of the plausible mechanisms of improving ADR by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. However, no RCT has been performed to evaluate the effect of CADe on WE colonoscopy.
Therefore, investigators will conduct a RCT comparing the ADR of CADe assisted colonoscopy inserted with either WE or insufflation. Our hypothesis will be that CADe assisted WE colonoscopy achieves higher ADR than CADe assisted air insufflation colonoscopy.
Read the detailed description
The primary end point will be ADR, defined as the proportion of patients with at least one adenoma. Serrated lesions will not be counted as part of ADR. Secondary outcomes were FP rate, adenomas per colonoscopy (APC), polyp detection rate, polyps per colonoscopy, SL detection rate, cecal intubation rate, withdrawal time. Missed polyp will be defined as a polyp recognized by endoscopist, but is not detected by CADe system at an interval of 2 seconds. The detected polyps will be classified in sizes, morphology (polypoid or nonpolypoid). Investigators also record the detection of every polyp by the endoscopist or the CADe system in time priority. If a polyp is detected by performing endoscopist at the same time as the CADe system, the credit will go to the endoscopist. The colonoscopy procedure will be recorded as CADe over-laid videos and be reviewed for FP characteristics, numbers and appearance time afterward. The withdrawal time will be divided into inspection time, cleaning time and polypectomy time. Boston Bowel Preparation Scale score and the amount of water infused and aspirated will also be recorded.
- Conditions
- Colon Adenoma, Colonoscopy
- Being tested
- Colonoscopy with water exchange or air insufflation methods
- Keywords
- adenoma detection rate, computer-aided system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with water exchange or air insufflation methodsDevice
Using computer-aided polyp detection algorithm on colonoscopy with water exchange or air insufflation methods. This computer-aided algorithm does not intervene directly the colonoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Water exchange | Active comparator | This group of participants receives water exchange colonoscopy with the computer-aided polyp detection system. Receives: Device: Colonoscopy with water exchange or air insufflation methods |
| Air insufflation | Active comparator | This group of participants receives air insufflation colonoscopy the computer-aided polyp detection system. Receives: Device: Colonoscopy with water exchange or air insufflation methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
proportion of patients with at least one colorectal adenoma detected among all patients examined by an endoscopist
Measured: During each colonoscopy procedure
Secondary outcomes (1)
false positive rate
number of false positive appears using the computer-aided polyp detection system in all participants
Measured: During each colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start16 May 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia Pei Tang, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448300
- Sponsor's protocol ID
- A11004002
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoma Detection Using Real-Time Computer-Aided Colon Polyp Detection System to Compare Water Exchange and Air Insufflation - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05448300
- Acronym / sponsor ID
- A11004002
- Conditions
- Colon Adenoma, Colonoscopy
- Keywords
- adenoma detection rate, computer-aided system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 7 Jul 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.
Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. A modified Delphi review reported water exchange showed the highest overall ADR, ADR in screening cases, and in the right side of the colon compared with water immersion and air (or CO2) insufflation. One of the plausible mechanisms of improving ADR by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. However, no RCT has been performed to evaluate the effect of CADe on WE colonoscopy.
Therefore, investigators will conduct a RCT comparing the ADR of CADe assisted colonoscopy inserted with either WE or insufflation. Our hypothesis will be that CADe assisted WE colonoscopy achieves higher ADR than CADe assisted air insufflation colonoscopy.
Detailed description
The primary end point will be ADR, defined as the proportion of patients with at least one adenoma. Serrated lesions will not be counted as part of ADR. Secondary outcomes were FP rate, adenomas per colonoscopy (APC), polyp detection rate, polyps per colonoscopy, SL detection rate, cecal intubation rate, withdrawal time. Missed polyp will be defined as a polyp recognized by endoscopist, but is not detected by CADe system at an interval of 2 seconds. The detected polyps will be classified in sizes, morphology (polypoid or nonpolypoid). Investigators also record the detection of every polyp by the endoscopist or the CADe system in time priority. If a polyp is detected by performing endoscopist at the same time as the CADe system, the credit will go to the endoscopist. The colonoscopy procedure will be recorded as CADe over-laid videos and be reviewed for FP characteristics, numbers and appearance time afterward. The withdrawal time will be divided into inspection time, cleaning time and polypectomy time. Boston Bowel Preparation Scale score and the amount of water infused and aspirated will also be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Water exchange | Active comparator | Device: Colonoscopy with water exchange or air insufflation methodsThis group of participants receives water exchange colonoscopy with the computer-aided polyp detection system. |
| Air insufflation | Active comparator | Device: Colonoscopy with water exchange or air insufflation methodsThis group of participants receives air insufflation colonoscopy the computer-aided polyp detection system. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients, undergoing screen, diagnostic or surveillance colonoscopy performed by the participating endoscopists will be enrolled.
Key exclusion criteria (1 listed)
- We excluded patients age < 50 or > 80 years old, undergone colonoscopy in the past 3 years, partial intake of bowel preparation, renal failure, previous colonic resection, scheduled for polypectomy, American Society of Anesthesiology (ASA) Risk Class 3 or higher, and lack of written informed consent.
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 |
|---|---|---|
| Colonoscopy with water exchange or air insufflation methodsUsing computer-aided polyp detection algorithm on colonoscopy with water exchange or air insufflation methods. This computer-aided algorithm does not intervene directly the colonoscopy procedure. | Device | Air insufflation, Water exchange |
Primary outcome
adenoma detection rate
Time frame: During each colonoscopy procedure
proportion of patients with at least one colorectal adenoma detected among all patients examined by an endoscopist
1 secondary outcome
false positive rate
Time frame: During each colonoscopy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
Related trials for Colon Adenoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Pancreatic Ductal Adenocarcinoma, Gastric Cancer
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 3
S0820, Adenoma and Second Primary Prevention Trial
Colorectal Neoplasms
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with water exchange or air insufflation methods in people with Colon Adenoma and Colonoscopy, run by Dalin Tzu Chi General Hospital at 2 sites in 2 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia Pei Tang, MD (0921128335, franktg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: During each colonoscopy procedure). 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 12 Jul 2022.